BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONICS

    MDR report key: 540404 · Received May 5, 2004

    Report

    Report Number
    540404
    Event Type
    Injury
    Date Received
    May 5, 2004
    Date of Event
    April 21, 2004
    Report Date
    May 5, 2004
    Manufacturer
    MEDTRONIC INC.
    Product Code
    DSZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PACEMAKER BATTERY REPLACED. THAT NIGHT PT COMPLAINED OF SEVERE MUSCLE SPASMS IN THAT AREA. NEXT MORNING PACEMAKER WAS REPROGRAMMED TO OBLATE STIMULATION BUT WITH NARROW SAFETY MARGIN. RETURNED TO SURGERY THAT AFTERNOON FOR PLACEMENT OF GENERATOR IN SUBCUTANEOUS POCKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONICS PACEMAKER BATTERY DSZ MEDTRONIC INC. KDR906 *

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention