BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR II V-185 AC SERIES TIERED THERAPY DEFIB

    MDR report key: 252078 · Received November 26, 1999

    Report

    Report Number
    MW4002635
    Event Type
    Injury
    Date Received
    November 26, 1999
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 1/19/00: ON 4/28/99, MFR PROVIDED THE PHYSICIAN THE RESULTS OF THE FAILURE ANALYSIS FOR THE SUBJECT DEVICE. ON 8/16/99 INITIAL RPTR MADE ADD'L QUERIES AND A RESPONSE WAS PROVIDED. ON 11/11 MFR RECEIVED A FAX FROM DR REQUESTING ADD'L INFO. ON 11/16/99, MFR PROVIDED THE PHYSICIAN THIS INFO ALONG WITH COPIES OF THE MDR AND FOLLOW-UP REPORTS. MFR ALSO INFORMED HIM THAT AS A RESULT OF INVESTIGATION OF THIS INCIDENT, MFR HAD MODIFIED ITS DESIGN TO ADD A SECOND, REDUNDANT INSULATION LAYER BETWEEN THE HIGH VOLTAGE CAPACITORS (REFERENCE SUBMISSION #P910023, SUPPLEMENT #45). DR CONTACTED TECHNICAL SVS DEPT AND FURTHER INFO WAS PROVIDED ON 11/19/99. MFR HAS REPORTED THIS EVENT AND ALL PERTINENT INFO AS REQUESTED TO FDA AND HAS SUPPLIED THIS INFO TO THE REPORTING PHYSICIAN. CURRENTLY, MFR HAS NO NEW INFO TO PROVIDE REGARDING THIS INCIDENT.

    Description of Event or Problem · 1

    RPTR WOULD LIKE TO FORMALLY REPORT SEVERAL FACTUAL INACCURACIES PRESENT IN MDR. RPTR IS THE PHYSICIAN OF RECORD FOR THIS PT AND RPTR MADE THE INITIAL REPORT TO THE MFR. IN THIS REPORT FILED BY THE MFR, THEY STATE THAT THE CLUSTER OF ABORTED EPISODES ON 1/18/99 WERE "DUE TO THE FIBRILLATION DETECTION RATE PROGRAMMED TOO CLOSE TO THE PT'S ACTUAL TACHYCARDIA RATE." ELECTROGRAM ANALYSIS FOR 1/18/99 CLEARLY SHOWS EACH EVENT TO BE NEW ONSET AND SEPARATE NONSUSTAINED VT. NOT AS THE CO ALLEGES, A LONG EPISODE OF SUSTAINED VT WHOSE CYCLE LENGTH FLUCTUATES AROUND THE PROGRAMMED RATE CUTOFF. THE REPORT ALSO STATES THAT DURING THE EPISODES OF 1/23/99 "ALL THERAPIES HAD BEEN DELIVERED AND WERE UNSUCCESSFUL ON CONVERTING THE ARRHYTHMIA TO A NORMAL SINUS RHYTHM." THE CO REP WERE AWARE THAT THERE NO NO NO EVIDENCE OF ANY SHOCK DELIVERY. THE ATTENDING MDR DID NOT OBSERVE MYOCLONIC ACTIVITY THAT TYPICALLY ACCOMPANIES ICD DISCHARGE, TELEMETRY SHOWED NO ENERGY DELIVERY, AND DEVICE INTERROGATION SHOWS NO ENERGY DELIVERED. THE REPORT THEN CONTINUES TO STATE THAT THE "ARRHYTHMIA, HOWEVER, BROKE ON ITS OWN." THE CO REP WAS AWARE THAT THE ARRHYTHMIA DEGENERATED TO VF AND REQUIRED EXTERNAL CARDIOVERSION FOR TERMINATION. FINALLY, THE FILED MDR IS INCORRECT IN THEIR REPORTING THAT "ST JUDE MEDICAL ADVISED THAT THE DEVICE BE REMOVED AND THE LEADS TESTED." THE CO REP DID NOT SUGGEST THAT DEVICE REMOVAL WAS INDICATED OR THAT CAPACITOR FUNCTION MAY BE ABNORMAL. IN FACT, THEY INSISTED THE PROBLEM WAS PROBABLY LEAD RELATED AND SUGGESTED REMOVAL OF THE ENTIRE SYSTEM. WHEN RPT INDICATED THAT INTERROGATION DATA ABSOLVED THE LEAD, THEY ONCE AGAIN INSISTED THAT IN THEIR ASSESSMENT THE MOST PROBABLE CULPRIT WAS THE LEAD. NEEDLESS TO SAY, RPTR FINDS THESE FACTUAL DISCREPANCIES VERY CONCERNING. THEY MISREPRESENT THIS OCCURRENCE AS A MINOR AND BENIGN PROBLEM. IN FACT, THIS WOULD HAVE RESULTED IN PT DEATH HAD THE PT NOT BEEN ON A TELEMETERED HOSP WARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR II V-185 AC SERIES TIERED THERAPY DEFIB IMPLANTABLE CARDIAC DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *