BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 83329 · Received February 12, 1997

    Report

    Report Number
    83329
    Event Type
    Injury
    Date Received
    February 12, 1997
    Date of Event
    August 13, 1996
    Report Date
    September 18, 1996
    Manufacturer
    BIOTRONIK, INC.
    Product Code
    DTD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS 87-YR-OLD MALE WITH HISTORY OF SICK SINUS SYNDROME TREATED WITH SINGLE CHAMBER PACEMAKER SUPPORT IN 1981 WITH REPLACEMENT IN 1995. AT THAT TIME HIS CHRONIC UNIPOLAR VENTRICULAR LEAD WAS RETAINED AND A LONG ADAPTER WAS USED TO ATTACH TO A PULSE GENERATOR. HIS COURSE SINCE THEN HAS SHOWN GRADUAL DETERIORATION IN UNIPOLAR IMPEDENCE, SUGGESTING INSULATION FAILURE. CLINICALLY SYMPTOMATIC OVERSENSING THREATENED THE VOO MODALITY. THE ADAPTER WAS REMOVED AND THE IMPEDENCE AND PACING THRESHOLD OIN THE CHRONIC INDWELLING VENTRICULAR LEAD WAS SATISFACTORY, INDICATING PROBABLE INSULATION BREAK INVOLVING THE ADAPTER ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * Implant PULSE GENERATOR ADAPTER DTD BIOTRONIK, INC. A1-A *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization