BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 117594 · Received July 7, 1997

    Report

    Report Number
    117594
    Event Type
    Injury
    Date Received
    July 7, 1997
    Date of Event
    June 13, 1997
    Report Date
    July 7, 1997
    Manufacturer
    MEDTRONIC, INC. MS T172
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    VARYING PACING IMPEDANCES OF THE DEVICE CAUSED NECESSITY OF RE-OPENING AND ANALYSIS. VARIANCE RANGED FROM <100->2000 JL @ 2V. OLD DEVICE WAS REMOVED DURING SURGERY AND A NEW DEVICE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC Implant PACEMAKER LWS MEDTRONIC, INC. MS T172 7223CX *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention