BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM

    MDR report key: 3041116 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01488
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 15, 2013
    Report Date
    March 28, 2013
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    KRG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE PROGRAMMER WAS THOROUGHLY EVALUATED. A COMPONENT ON THE INPUT/OUTPUT PRINTED CIRCUIT BOARD (PCB) WAS FOUND TO BE DAMAGED. THE PCB WAS REPLACED AND THE PROGRAMMER THEN PASSED ALL FUNCTIONAL TESTING.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT WHILE THIS PROGRAMMER WAS BEING USED, SMOKE APPEARED FROM THE FLOPPY DISK DRIVE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143308 ZOOM KRG EXTERNAL MANUFACTURER 3120

    Patients

    Seq Age Sex Outcome Treatment
    1