BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 159499 · Received January 28, 1998

    Report

    Report Number
    159499
    Event Type
    Injury
    Date Received
    January 28, 1998
    Date of Event
    November 28, 1997
    Report Date
    January 28, 1998
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    ROUTINE PHONE EVALUATION ON 11/24/1997 SHOWED EPISODES OF OVERSENSING WITH PAUSES. IN CLINIC, EVALUATION ON 11/25/1997 SHOWED FURTHER EPISODES OF OVERSENSING AT LEAST SENSITIVE SETTINGS AND PAUSES UP TO 3 SECONDS. DOCUMENTED WITH RHYTHM STRIPS AND MARKER CHANNELS. UNABLE TO PROGRAM TO CORRECT THE PROBLEM. MODERATE TO COMPLETE PACEMAKER DEPENDENCY. PT ADMITTED FOR SURGICAL REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC Implant LEAD (EPICARDIAL) DTB MEDTRONIC, INC. 5069-35 *

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Hospitalization| R