‘and in support thereof alleges: Aug 30 2007 12:26 fug 30 2007 12:24 P, STATE OF FLORIDA DEPARTMENT OF HEALTH DEPARTMENT OF HEALTH, PETITIONER, v. CASE NO. 2005-01644 RAMABHADRAN VASUDEVAN, M.D., RESPONDENT. / ADMI TIV! NT COMES NOW, Petitioner, Department of Health, by and through its undersigned counsel, and files this Administrative Complaint before the Board of Medicine against the Respondent, Ramabhadran Vasudevan, M.D., 1, Petitioner is the state department charged with regulating the practice of medicine pursuant to Section 20.43, Florida Statutes; Chapter 456, Florida Statutes; and Chapter 458, Florida Statutes. 2. Respondent's address of record is 1040 S.W. Second Avenue, Ocala, FL 34474. 3. Respondent is board certified in Cardiology/Internal Med Ramabhadran Vasudevan, M.D, Case 2005-01644 cine. feo 4 _ Aug 30 2007 12:26 fug 30 2007 12:24 P.03 4. At all times material to this complaint, Respondent; was a licensed physician within the State of Florida, having been issued! license number 51747, 2. On or about November 5, 2004, Patient K.M., a then sixty one (61) year-old male, had a dual chamber implantable defibrillator (ICD) implanted by the Respondent at the Monroe Regional Medical} Center (MRMC), Ocala, Florida, The procedure was uneventful and the patient was discharged that evening, 6. On or about November 7, 2004, Patient K.M. was experiencing chest pain and on or about November 8, 2004, went to Respondent's office where the device was examined and found to be functioning properly. 7, Patient K.M. continued to experience chest pain and) on or about Novernber 12, 2004, returned to Respondent's. office for | suture removal. The devise was examined again and tested appropriately, but no diagnosis of the patient problem was made. While there is a note)in the chart stating, “Dr. Ram came and saw the pt. today...," the documentation | inadequately provides any details of the Respondent's involvement with this patient, if any, Ramabhadran Vasudevan, M.D. Case 2005-01644 2 Aug 30 2007 12:26 fug 30 2007 12:24 P. O04 8. Patient K.M. continued to experience increasingly intense, constant pain and was unable to sleep, On or about November 19, 2004, he returned to Respondent's office. Patient K.M. was sent to an outpatient center for x-rays and returned with the films as well as the post-operative x-ray he obtained from MRMC. An echocardiogram (echo) was performed at Respondent's office which he concluded did not show anything of concern. The device was evaluated and found to have a significant reduction in sensing and a significant increase in pacing threshold; but the impedance was unchanged. 9. On or about November 20, 2004, Patient K.M. went to/a local emergent care center but was not fully evaluated due to the recent ICD insertion. The next day he went to the MRMC emergency room| where several tests were performed and he was administered IV hydration and anti-inflammatory medication, He was released without contact with the Respondent or the on-call cardiologist. . | 10. On or about November 22, 2004, Patient K.M advised by telephone that the pain medication was not strong enough and Respondent Called in additional pain medication. Ramabhadran Vasudevan, M.D. Case 2005-01644 , 3 Aug 30 2007 12:27 fug 30 2007 12:24 P.O5 11. On or about November 24, 2004, Patient K.M. passed out at home and was resuscitated by paramedics and brought to MRMC where he was diagnosed with a massive left hemothorax. Immediate surgery was performed revealing that the ICD lead had perforated both the right ventricle and the pericardium. 12. Shortly thereafter, a re-exploration for continued bleeding was performed adjacent to where the lead tip had eroded. The patient developed respiratory distress and multi-organ failure and died on December 8, 2004. 13. Patient K.M. had the appropriate symptoms, tests and ICD lead information to make an appropriate diagnosis of a lead perforatian.. The medical records disclose that the Respondent only saw the patient once post-operatively (on November 8, 2004). All other visits were conducted by _ an office staff person identified as J.H. There also appears to be two pages recording the several November 2004 visits with questionable additions that may have been made later and relate to Respondent's involvement. 14. There is no documentation of a careful assessment/examination by Respondent of the nature of Patient K.M/’s worsening chest pain or of a Suspected etiology. The pain was located over the apex of the heart, not Ramabhadran Vasudevan, M.D. Case 2005-01644 4 Aug 30 2007 12:27 fug 30 2007 12:26 P. O06 near the incision, indicating until proven otherwise, that a perforation may have occurred. 15. Respondent read the November 19, 2004, echo as showing no obvious perforation. He compared the November 19, 2004 x-rays with the post-op film and noted that the tip of the lead was curved, but he presumed it was “secondary to lead redundancy.” A curved tip is an indicator of a perforation and signifies that the lead tip was upwardly deflected by the pericardium or chest wall and is a clear deviation from the original placement. The changes in the ICD, i.e,, a significant reduction in sensing and a significant increase in pacing threshold, were also sighs of a significant problem with the device, 16. Respondent failed to timely evaluate and diagnose Patient K.M.’s abnormal pain following the ICD insertion. COUNT I 17, Petitioner realleges and incorporates paragraphs one (1) through seventeen (17) as if fully set forth herein. 18. Section 458,331(1)(t), Florida Statutes (2004), provides that failing to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as Ramabhadran Vasudevan, M.D. Case 2005-01644 being Aug 30 2007 12:27 fug 30 2007 12:26 P.O? acceptable under similar conditions and circumstances constitutes grounds for disciplinary action by the Board of Medicine. 19. Respondent failed to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent! similar physician as being acceptable under similar conditions and circumstances in one or more of the following ways: a) by failing to adequately address Patient K.M.’s chest pain on November 8, 2004, the first post-operative day; b) by failing to adequately address and diagnosis the cause of Patient K.M.'s continued chest pain at the November 12, 2004, office visit; ¢) by failing to adequately address Patient K.M/s increasing, intense, constant pain and inability to sleep at the November 19, 2004, office visit; d) by incorrectly reading the November 19, 2004, echo as showing no obvious perforation; €) by incorrectly comparing the November 19, 2004,|-x-rays with the post-op film noting that the tip of the lead was curved, but presuming it was “secondary to lead redundancy,” whereas a curved tip is an indicator of a perforation; f) by failing to find that the changes' in the ICD (significant reduction in sensing and significant increase in |pacing threshold) were signs of a significant problem with the device; g) by failing to adequately recognize that Patient K.M. had the appropriate symptoms, Ramabhadran Vasudevan, M.D. Case 2005-01644 6 Aug 30 2007 12:27 dug 30 2007 12:26 P. 08 tests and ICD lead information to make an appropriate diagnosis of a lead perforation; h) by only seeing the patient once post-operatively on November 8, 2004, with all other visits conducted by a staff !person identified as J,H.; i) by failing to adequately perform or document a careful assessment/examination of the nature of Patient K.M/s worsening chest pain or to identify a suspected etiology; e) by failing to maintain medical records that adequately justified the course of treatment, 20. Based on the foregoing, Respondent has violated Section 458.331(1)(t), Florida Statutes (2004), by failing to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. COUNT II 21. Petitioner realleges and incorporates paragraphs one (1) through seventeen (17) as if fully set forth herein, 22. Section 458.331(1)(m), Florida Statutes (2004), provides that failing to keep legible medical records that justify the course of treatment of the patient, including, but not limited to, patient histories; examination results; test results; records of drugs prescribed, dispensed, or Ramabhadran Vasudevan, M.D. Case 2005-01644 7 Aug 30 2007 12:28 dug 30 2007 12:26 P.09 administered; and reports of consultations and hospitalizations, constitutes grounds for disciplinary action by the Board of Medicine, | 23. Respondent failed to keep records justifying the course of treatment in one or more of the following ways: a) for one or more of the November 2004 visits, by inappropriately recording late additions that addressed the Respondent's involvement in the evaluation, care or treatment of Patient K.M.; b) by failing to maintain medical records that adequately justified the course of treatment, 24. Based on the foregoing, Respondent. . violated $ection 458.331(1)(m), Florida Statutes (2004), by failing to keep legible medical records that justify the course of treatment of the patient, including, but not limited to, patient histories; examination results; test results; records of drugs prescribed, dispensed, or administered; and reports of consultations and hospitalizations, WHEREFORE, the Petitioner respectfully requests that the Board of Medicine enter an order imposing one or more of the following penalties: permanent revocation or suspension of Respondent's license, restriction of practice, imposition of an administrative fine, issuance of a reprimand, placement of the Respondent on probation, corrective action, refund of Ramabhadran Vasudevan, M.D, Case 2005-01644 ty Aug 30 2007 12:28 fug 30 2007 12:26 P.10 fees billed or collected, remedial education and/or any other relief that the Board deems appropriate. SIGNED this] “"_ day of Tone. 2007, Ana M. Viamonte Ros, M.D., MPH Secretary, Department of Health By: Irving/ Levine Assistant ‘General Counsel DOH-Prosecution Services Unit SE APU Ba 4052 Bald Cypress Way-Bin C-65 4 Tallahassee, Florida 32399-3265 Florida Bar # 0822957 (850) 245-4640, ext 8128 (850) 245-4681 fax PCP: Sune F 2007 PCP Members: Leon, Savav, Beebe Ramabhadran Vasudevan, M.D, Case 2005-01644 9 Aug 30 2007 12:28 fug 30 2007 12:26 P.11 I IGHT: Respondent has the right to request a hearing| to be conducted in accordance with Section 120.569 and 120.57, Florida Statutes, to be represented by counsel or other qualified representative, to present evidence and argument, to call and cross-examine witnesses and to have subpoena and subpoena duces tecum issued on his or her behalf if a hearing is requested. CE REGA ENT OF Respondent is placed on notice that Petitioner has incurred costs related to the investigation and prosecution of this matter. Pursuant to Section 456.072(4), Florida Statutes, the Board shall assess costs related to the investigation and prosecution of a disciplinary matter, which may include attorney hours and costs, on the Respondent in addition to any other discipline imposed. Ramabhadran Vasudevan, M.O, Case 2005-01644 10

Docket for Case No: 07-003954PL