BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 3904589 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-09489
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    April 15, 2014
    Report Date
    July 29, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT ALONG WITH THE SHORTED LEAD FAULT, A LOW OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT WAS NOTED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED A MANUAL CAPACITOR REFORM WHICH WAS DONE AND IT APPEARED AS IF THE PACEMAKER WAS UNAFFECTED BY THE SHORT BUT RECOMMENDED AN EVALUATION AND CONSIDER REMOVING BOTH THE PG AND LEAD. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A SHORTED SHOCK LEAD FAULT UPON INTERROGATION. THERE WERE FOUR SHOCKS DELIVERED EARLIER IN THE DAY. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT IF THE DEVICE DELIVERED SHOCKS TO A SHORTED CONDITION, THE DEVICE AND LEAD SHOULD BE REPLACED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383569 ENDOTAK ENDURANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0154

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR 1860| T175| 0154