BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2170298 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-11827
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THIS RV LEAD REMAINS ACTIVELY IN SERVICE. IN FURTHER TROUBLESHOOTING , THE ASSOCIATED ICD WAS REMOVED FROM SERVICE. BOSTON SCIENTIFIC FINAL ANALYSIS COULD NOT CONFIRM NOR DENY THE PHYSICIAN'S CONCERN FOR SUB-PECTORAL ADVISORY RELATED DEVICE BEHAVIOR AND POSSIBLE SHORTED CONDITION. ANALYSIS OF THE RETURNED DEVICE SHOWED THE MISSING DAILY MEASUREMENTS WERE DUE TO CORRUPTED DATA BEING WRITTEN TO DEVICE MEMORY, THAT THE CAUSE OF THE CORRUPTED DATA COULD NOT BE DETERMINED, THAT INITIAL TESTING CONFIRMED ALL THERAPIES WERE AVAILABLE, AND HOW AFTER THE DEVICE FIRMWARE WAS RELOADED AND THE DEVICE PROGRAMMED TO THE SAME CLINICAL SETTINGS, NO ANOMALIES WITH THE LEAD MEASUREMENTS WERE NOTED. SUBSEQUENTLY, TESTING AGAIN CONFIRMED ALL THERAPIES WERE AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD DID EXHIBIT ERRATIC LOW SHOCK AND LOW PACE IMPEDANCE MEASUREMENTS DURING ROUTINE DEVICE FOLLOW UP, WHICH MAY BE THE RESULT OF A SHORTED LEAD CONDITION OR OTHER LEAD INTEGRITY ISSUE. THERE WAS NO NOISE PRESENT AND NO SHOCKS HAD BEEN DELIVERED. ONLY 1 ANTITACHYCARDIA PACING (ATP) WAS PRESENT. THE BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT RECOMMENDED FURTHER TROUBLESHOOTING SUCH AS SYNCHRONIZED 1.1 JOULES SHOCK AND SYNCHRONIZED MAXIMUM ENERGY SHOCK TO TEST THE INTEGRITY OF THE DEVICE SYSTEM AND TO ALSO CONSIDER THIS PATIENT UNPROTECTED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS BEYOND THE CONCERN FOR A SHORTED CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention 1861| A155| 6936| E110| 0185| 4471| (B)(4)| 6933