BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AICD

    MDR report key: 20253 · Received March 14, 1995

    Report

    Report Number
    MW1005429
    Event Type
    Injury
    Date Received
    March 14, 1995
    Date of Event
    February 17, 1995
    Report Date
    February 27, 1995
    Manufacturer
    MEDTRONIC BIO-MEDICUS, INC.
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT EXPERIENCED PAIN AROUND DEFIBRILLATOR SITE WHEN MOVING LEFT ARM. PT MONITORED IN ICU, PACEMAKER NOT FIRING AND PT HAD NO DYSRHYTHMIA'S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AICD Implant AICD LWS MEDTRONIC BIO-MEDICUS, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization| R