BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC

    MDR report key: 379821 · Received March 1, 2002

    Report

    Report Number
    379821
    Event Type
    Death
    Date Received
    March 1, 2002
    Date of Event
    October 23, 2001
    Report Date
    February 25, 2002
    Manufacturer
    MEDTRONIC INC
    Product Code
    DRO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PACER SPIKE ON T-WAVE CAUSING V-FIB ARREST. PACER STONED WITH ANOTHER PACER (AFTER ARREST) UNABLE TO BE SURE WHICH ONE WAS USED. BOTH PACERS SENT TO MEDTRONIC FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC SINGLE CHAMBER TEMP PACER AA1/VV1 DRO MEDTRONIC INC 5348 *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| O