BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOLAR VENTRICULAR ENDOCARDIAL LEAD

    MDR report key: 119341 · Received July 11, 1997

    Report

    Report Number
    2017865-1997-00835
    Event Type
    Injury
    Date Received
    July 11, 1997
    Date of Event
    February 20, 1997
    Report Date
    April 24, 1997
    Manufacturer
    PACESETTER INC.
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED WITH RETURN OF THE EXPLANTED DEVICE NOTES MUSCLE STIMULATION AND THAT THE PATIENT COMPLAINED OF BEING SH OCKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR VENTRICULAR ENDOCARDIAL LEAD Implant PERMANENT PACEMAKER ELECTRODE DTB PACESETTER INC. 1226T/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention