BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRON

    MDR report key: 84406 · Received April 11, 1997

    Report

    Report Number
    1640319-1997-00319
    Event Type
    Malfunction
    Date Received
    April 11, 1997
    Date of Event
    March 17, 1997
    Report Date
    April 11, 1997
    Manufacturer
    SULZER INTERMEDICS INC.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE FIRST AND SECOND NIPS INDUCTION, A NON-SUSTAINED ARRHYTHMIA WAS OBSERVED. THE THIRD NIPS INDUCTION RESULTED IN RX REPORTS " DEVICE BUSY", HOWEVER, NIPS WAS DELIVERED. FIBRILLATION WAS INDUCED BY STEP 3, AND NOT DETECTED FOR APPROXIMATELY 20 SECONDS. THE DEVICE DETECTS FIBRILLATION AND BEGINS CHARGING FOR THERAPY D. A RESCUE SHOCK WAS REQUESTED DURING CHARGING, PRODUCING NOISE EVENT. THERAPY D WAS DELIVERED, AND TERMINATED FIBRILLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRON Implant IMPLANTABLE DEFIBRILLATOR LWS SULZER INTERMEDICS INC. 101-09 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR