BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK PLUS TRANSVENOUS DEFIBRILLATION LEAD IS-1

    MDR report key: 74051 · Received January 16, 1997

    Report

    Report Number
    2124215-1997-00632
    Event Type
    Injury
    Date Received
    January 16, 1997
    Date of Event
    November 6, 1996
    Report Date
    November 6, 1996
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS ENDOTAK PLUS TRANSVENOUS LEAD (0075) WAS REMOVED FROM A PATIENT, BECAUSE AT FOLLOW UP THE PACING IMPEDANCE HAD DECREASED FROM 500 OHMS TO 210-250 OHMS. WHEN THEY WENT IN INVASIVELY, THEY FOUND AN INSULATION BREAK IN THE LEAD. IT WAS REMOVED FROM SERVICE AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK PLUS TRANSVENOUS DEFIBRILLATION LEAD IS-1 Implant TRANVENOUS LEAD LWS CARDIAC PACEMAKERS 0075 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention THE DEVICE 1720/252732 WAS IMPLANTED 04-AUG-1995