BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIAC PACEMAKERS, INC

    MDR report key: 143684 · Received January 9, 1998

    Report

    Report Number
    143684
    Event Type
    Injury
    Date Received
    January 9, 1998
    Date of Event
    December 29, 1997
    Report Date
    January 9, 1998
    Manufacturer
    CARDIAC PACEMAKERS, 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

    ICD WAS DELIVERING INAPPROPRIATE SHOCKS WHILE PT WAS IN SINUS RHYTHM. THE LEAD WAS SUSPECTED TO BE FRACTURED BECAUSE PACING IMPEDANCE WENT FROM 500 OHMS TO 0 OHMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIAC PACEMAKERS, INC Implant LEAD LWS CARDIAC PACEMAKERS, INC./ ELI LILLY AND CO. 115 *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R