BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3211309 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08421
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 28, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CHRONIC IMPLANTABLE DEFIBRILLATION LEAD WAS SURGICALLY ABANDONED. A NEW LEAD AND DEVICE WERE SUCCESSFULLY IMPLANTED. THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THE ICD IDENTIFIED NO ANOMALIES. REVIEW OF DEVICE MEMORY FOUND A SHORTED LEAD FAULT , A SINGLE BIT MEMORY FAULT AND A LEAD LEAKAGE IN SESSION FAULT. AN X-RAY OF THE DEVICE REVEALED THAT THE INTERNAL HIGH VOLTAGE FUSE WAS DAMAGED (I.E., NO LONGER INTACT). THE DAMAGE TO THE FUSE MOST LIKELY OCCURRED DURING DELIVERY OF THE SHOCK THAT RESULTED IN THE SHORTED SHOCK LEAD FAULT.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE DEVICE REPLACEMENT, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IMPLANTED WITH THE CHRONIC IMPLANTABLE DEFIBRILLATION LEAD. DURING DEFIBRILLATION THRESHOLD (DFT) TESTING, THE DEVICE DELIVERED A SHOCK AND A SHORT CIRCUIT WARNING MESSAGE WAS OBSERVED. THE PATIENT REQUIRED EXTERNAL DEFIBRILLATION. THE DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). DURING DFT TESTING WITH THE NEW DEVICE, A SHORT CIRCUIT WARNING MESSAGE WAS AGAIN OBSERVED FOLLOWING SHOCK DELIVERY. ALL LEAD MEASUREMENTS WERE OBSERVED TO BE STABLE AND ACCEPTABLE, HOWEVER, A LEAD ISSUE WAS SUSPECTED. ONE OF THE DF PINS OR YOKE INSULATION WAS SUSPECTED TO BE WORN OUT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310970 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E141

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR T135| E140| E141| 0175| E051