BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMMUNICATOR

    MDR report key: 2950571 · Received February 8, 2013

    Report

    Report Number
    2124215-2013-02743
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    August 13, 2012
    Report Date
    October 3, 2012
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LATITUDE COMMUNICATOR EXHIBITED DAMAGE THAT IS CONSISTENT WITH A HIGH-POWER ELECTRICAL OVERSTRESS EVENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55056 COMMUNICATOR ACCESSORY LWS EXTERNAL MANUFACTURER 6481

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR 0185| 4470| T125