BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3212565 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09472
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 28, 2013
    Report Date
    June 18, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THE CRT-D IDENTIFIED AN ARC MARK ON THE DEVICE CASE. INTERROGATION OF THE DEVICE REVEALED A WARNING MESSAGE THAT THE CHARGE TIME EXCEEDED THE LIMIT. A CHARGE TIME OF 45 SECONDS WAS NOTED DURING A CAPACITOR REFORMATION. 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. THE DAMAGE TO THE HIGH VOLTAGE FUSE PREVENTED ANY SUBSEQUENT CHARGING OF THE HIGH VOLTAGE CAPACITORS AND DELIVERY OF SHOCK THERAPY.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE ATTEMPTED IMPLANT OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WITH ANOTHER MANUFACTURER'S CHRONIC IMPLANTABLE DEFIBRILLATION LEAD, THE DEVICE WAS OBSERVED TO HAVE SHORTED DURING DEFIBRILLATION THRESHOLD (DFT) TESTING. THE PATIENT WAS EXTERNALLY DEFIBRILLATED AND ANOTHER CRT-D WAS ATTEMPTED, BUT NOT IMPLANTED DUE TO HIGH DFTS. ANOTHER MANUFACTURER'S DEVICE WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313922 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND N141

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR 1388TC| 0186| MISMATCH| T180| H227| 5071| N141