BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMMUNICATOR

    MDR report key: 1880053 · Received October 22, 2010

    Report

    Report Number
    2124215-2010-20575
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 22, 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 POWER BRICK CASE WAS OBSERVED TO BE MELTED AND THE POWER BRICK BECAME EXCESSIVELY HOT DURING ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE COMMUNICATOR POWER CORD BECAME HOT TO THE TOUCH DURING SETUP OF THE COMMUNICATOR. 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 49 YR (B)(4)| (B)(4)