BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RES QII ACD

    MDR report key: 147123 · Received January 5, 1998

    Report

    Report Number
    147123
    Event Type
    Injury
    Date Received
    January 5, 1998
    Date of Event
    August 29, 1995
    Report Date
    September 15, 1997
    Manufacturer
    INTERMEDICS INC
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MALFUNCTION OF ICD GENERATOR. CAPACITOR/REFORM CHARGING CIRCUIT DEFECT SHOWED PROLONGED CHARGE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RES QII ACD ICD GENERATOR LWS INTERMEDICS INC 101-03 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention SENSING AND PACING LEADS.