BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 3211253 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-09354
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 20, 2013
    Report Date
    October 8, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    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, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NUMEROUS SCRATCHES AND TOOL MARKS IN THE HEADER AND THE CASE OF THE DEVICE, CONFIRMING THAT TOOLS WERE USED ON THE HEADER. HIGH POWERED VISUAL INSPECTION CONFIRMS THAT THE HEADER HAD BEEN PROPERLY ADHERED TO THE CASE OF THE DEVICE PRIOR TO THE INDUCED DAMAGE. ADEQUATE MEDICAL ADHESIVE WAS PRESENT ON THE DEVICE TO CONFIRM THIS. IT IS CONCLUDED THAT THE DEVICE MEETS SPECIFICATIONS FOR NORMAL BATTERY DEPLETION. IT IS CONCLUDED THAT THE DAMAGE TO THE DEVICE WAS INDUCED.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS CURRENTLY UNDERGOING DETAILED ANALYSIS. THIS EVENT WILL BE UPDATED UPON COMPLETION OF ANALYSIS

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED FOR NORMAL BATTERY DEPLETION (NBD). AS THE PHYSICIAN WAS PULLING THE DEVICE OUT OF THE POCKET, THE HEADER BECAME LOOSE. THE PHYSICIAN REPORTED PULLING ON THE HEADER WITH A TOOL AND WIGGLING THE HEADER BUT DID NOT THINK IT WAS TOO EXCESSIVE. THERE WAS NO SIGN OF ANY ISSUE PRIOR TO THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310649 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR LWP GUIDANT CRM CLONMEL IRELAND H210

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR H210| 4543| 4470| N161| 0185