BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFIENT

    MDR report key: 3905607 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11542
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    May 19, 2014
    Report Date
    August 15, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY EVALUATED. VISUAL INSPECTION OF THE DEVICE HEADER AND CASE DID NOT REVEAL ANY ANOMALIES. IT WAS CONFIRMED THAT THE DEVICE HAD NO TELEMETRY AND A MEMORY DOWNLOAD COULD NOT BE PERFORMED. THE DEVICE CASE WAS OPENED IN ORDER TO ASSESS THE INTERNAL COMPONENTS. INITIAL ELECTRICAL TESTING REVEALED AN ISSUE WITH THE TRANSFORMER THAT RESULTED IN ELECTRICAL OVERSTRESS DAMAGE TO THE POWER SUPPLY CIRCUITRY. DETAILED ANALYSIS DETERMINED THE INABILITY TO INTERROGATE THIS DEVICE WAS DUE TO THE ELECTRICAL OVERSTRESS DAMAGE. THIS RESULTED IN A HIGH CURRENT DRAIN, WHICH DEPLETED THE BATTERY MORE QUICKLY THAN EXPECTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE IN-CLINIC FOLLOW UP, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS UNABLE TO BE INTERROGATED WITH TWO DIFFERENT PROGRAMMERS AND AN OUT OF RANGE TELEMETRY MESSAGE WAS OBSERVED. ADDITIONALLY, NO TONES WERE EMITTED FROM THE DEVICE WITH MAGNET PLACEMENT. THE DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384835 CONFIENT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E030

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R 0154| 1860| E030