BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM

    MDR report key: 2910044 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15354
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    April 15, 2008
    Report Date
    November 1, 2012
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    KRG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROGRAMMER WAS RETURNED FOR ANALYSIS AND THE CLINICAL OBSERVATION WAS CONFIRMED. ADDITIONALLY, VISUAL INSPECTION FOUND PORTIONS OF THE INTERNAL CIRCUITRY WERE PHYSICALLY ALTERED. THE PROGRAMMER WAS SUCCESSFULLY REPAIRED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DIFFICULTY WAS EXPERIENCED WITH THIS PROGRAMMER'S PRINTER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18960 ZOOM KRG EXTERNAL MANUFACTURER 3120

    Patients

    Seq Age Sex Outcome Treatment
    1