BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELECTRONICS

    MDR report key: 113144 · Received July 17, 1997

    Report

    Report Number
    113144
    Event Type
    Injury
    Date Received
    July 17, 1997
    Date of Event
    April 15, 1997
    Report Date
    April 24, 1997
    Manufacturer
    TELECTRONICS PACING SYSTEMS
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT REPORTED FEELING OCCASIONAL "SHOCKS" IN CHEST. DURING ROUTINE EVALUATION, PACEMAKER INDICATED "DEPLETED BATTERY". DURING PACEMAKER REPLACEMENT, THE PHYSICIAN NOTICED BLOOD WITHIN THE VENTRICULAR PACEMAKER ELECTRODE AND REPLACED IT ALSO. UPON EXAMINING THE ELECTRODE, THE CONDUCTOR WAS FOUND TO BE EXPOSED IN SEVERAL PLACES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELECTRONICS Implant VENTRICULAR PACEMAKER LEAD DTB TELECTRONICS PACING SYSTEMS 330-201 *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention EXPLANTED| PACEMAKER: TELECTRONICS MODEL 1250H, IMPLANTED