BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAM MODULE

    MDR report key: 78131 · Received March 17, 1997

    Report

    Report Number
    1640319-1997-00243
    Event Type
    Malfunction
    Date Received
    March 17, 1997
    Date of Event
    February 12, 1997
    Report Date
    March 11, 1997
    Manufacturer
    SULZER INTERMEDICS INC.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE RPTR INDICATED THAT DURING A ROUTINE FOLLOW-UP, THEY HAD DIFFICULTY COMMUNICATING WITH THE DEVICE AND THE PROGRAMMER "LOCKED" UP. IT WAS TURNED OFF THEN ON-INQ-MESSAGE DEVICE DISABLED-RENABLED DEVICE. THE FINAL ITP (INQUIRE, TELEMETRY AND PRINT) WAS PERFORMED WITHOUT PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAM MODULE PROGRAM MODULE LWS SULZER INTERMEDICS INC. 531-30 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * 101-01-10581 (DEFIBRILLATOR)