BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIAC PACEMAKERS, INC.

    MDR report key: 106696 · Received July 15, 1997

    Report

    Report Number
    106696
    Event Type
    Injury
    Date Received
    July 15, 1997
    Date of Event
    July 5, 1997
    Report Date
    July 15, 1997
    Manufacturer
    CARDIAC PACEMAKER, INC. ELI LILLY AND CO.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INSULATION BREAK ON LEAD REQUIRING LEAD EXTRACTION ON ICD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIAC PACEMAKERS, INC. Implant LEAD LWS CARDIAC PACEMAKER, INC. ELI LILLY AND CO. 0064 *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R