BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2124215-2012-17113

    MDR report key: 2913671 · Received January 14, 2013

    Report

    Report Number
    2124215-2012-17113
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON ADDITIONAL INFORMATION THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECIEVED INFORMATION THAT THIS DEVICE WAS ALLEGED TO HAVE DEPLETED PREMATURELY. THIS DEVICE REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19967 LWS GUIDANT PUERTO RICO BV TACHY DEVICE

    Patients

    Seq Age Sex Outcome Treatment
    1