BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMMUNICATOR

    MDR report key: 1944594 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-19735
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    September 27, 2010
    Report Date
    October 8, 2010
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMMUNICATOR WAS RETURNED FOR ANALYSIS. THE POST MARKET QUALITY ASSURANCE LABORATORY CONFIRMED THE REPORTED ALLEGATION. THE RETURNED POWER SUPPLY WAS OBSERVED TO BE EXCESSIVELY HOT WHEN PLUGGED IN AND THE INSULATION WAS SPLIT OPEN.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE COMMUNICATOR WOULDN'T POWER ON AND THE POWER SUPPLY WAS HOT TO THE TOUCH. NO ADVERSE PATIENT EFFECTS REPORTED. A REPLACEMENT COMMUNICATOR WAS SHIPPED TO THE PATIENT.

    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 88 YR (B)(4)| (B)(4)| (B)(4)| MISMATCH| (B)(4)| (B)(4)