BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMMUNICATOR

    MDR report key: 1946065 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20092
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    October 4, 2010
    Report Date
    October 14, 2010
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    POST MARKET QUALITY ASSURANCE LAB CONFIRMED THE ALLEGATION FROM THE FIELD. THE POWER SUPPLY WAS CONFIRMED TO BE EXCESSIVELY HOT TO THE TOUCH AND DISPLAYED AN AUDIBLE RINGING COULD BE HEARD DURING TESTING. THE POWER SUPPLY WAS OBSERVED TO HAVE MELTING TO THE CASE DURING ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT'S COMMUNICATOR HAD NO POWER TO IT. THE POWER SUPPLY BECAME HOT TO THE TOUCH. NO ADVERSE PATIENT EFFECTS OR INJURIES REPORTED. NO LONGER IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMMUNICATOR ACCESSORY LWS EXTERNAL MANUFACTURER 6476

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR (B)(4)| (B)(4)| (B)(4)