BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 176581 · Received April 24, 1998

    Report

    Report Number
    176581
    Event Type
    Injury
    Date Received
    April 24, 1998
    Date of Event
    April 3, 1998
    Report Date
    April 24, 1998
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PACEMAKER AND VENTRICULAR LEAD IMPLANTED 2/13/1993. PT DEVELOPED FAILURE TO PACE AND SENSE. THIS WAS CORRECTED BY TURNING UP THE VOLTAGE TO MAXIMUM OUTPUT WHICH ALLOWED SATISFACTORY PACING, HOWEVER, THE BATTERY WAS DEPLETED SOMEWHAT SOONER AS A RESULT. BATTERY/PACEMAKER CHANGED OUT FOR END OF LIFE ON 4/3/1998. VENTRICULAR LEAD CAPPED DUE TO POOR POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC Implant VENTRICULAR LEAD DTB MEDTRONIC, INC. 5024M UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention SPIRIONOLACTONE 25 BID, LASIX 2- QOD, LEVOTHROID| 500 QD.| HYDREA 500, 2 TABS AM, 1 PM. TICLID 250 BID,| 25 MCG QD, VIT E 1000U QD, ARICEPT 5 MG QD, VIT C