BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC INC.

    MDR report key: 292323 · Received August 17, 2000

    Report

    Report Number
    292323
    Event Type
    Injury
    Date Received
    August 17, 2000
    Date of Event
    August 8, 2000
    Report Date
    August 17, 2000
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT POST OPEN HEART, ATRIAL SEPTAL DEFECT REPAIR AND MITRAL VALUE RING ANNULOPLASTY. EPICARDIAL WIRE EXTERNALLY PACED FOR NO P-WAVES & VERY SLOW JUNCTIONAL RHYTHM UNDERNEATH. PACER SHUT ITSELF OFF SPONTANEOUSLY WITH PT PRESSURE DROPPING TO ESSENTIALLY NOTHING. PACER WAS RESTARTED WITH PT RECOVERY. PACER WAS (ELECTRONICALLY) LOCKED, HANGING ON IV POLE. LAST SETTINGS HAD BEEN CHANGED 3-5 MIN. EARLIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC INC. EXTERNAL PACEMAKER DTE MEDTRONIC, INC. 5388 *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening| R