BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM

    MDR report key: 3041282 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01407
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    November 15, 2012
    Report Date
    January 11, 2013
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    KRG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE PROGRAMMER WAS PERFORMED. VISUAL INSPECTION FOUND THAT THE PROGRAMMERS INSULATOR AND BOTTOM HOUSING WAS MELTED FROM A BURNT CIRCUIT. LABORATORY ANALYSIS CONFIRMED THE CLINICAL OBSERVATION OF A BURNING SMELL. THE INSULATOR, BOTTOM HOUSING, AND CIRCUIT WAS SUCCESSFULLY REPLACED AND REPAIRED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PROGRAMMER SMELLED LIKE BURNT WIRE WHEN BOOTED UP. THE PROGRAMMER WILL BE RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142793 ZOOM KRG EXTERNAL MANUFACTURER 3120

    Patients

    Seq Age Sex Outcome Treatment
    1