BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 372277 · Received January 17, 2002

    Report

    Report Number
    372277
    Event Type
    Injury
    Date Received
    January 17, 2002
    Date of Event
    January 15, 2002
    Report Date
    January 16, 2002
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A ROUTINE PACEMAKER CHECK DONE IN 10/2001 DISPLAYED A BATTERY VOLTAGE OF 2.66 VOLTS. INTERROGATION DONE ON EVENT DATE REVEALED THAT IN 10/2001 PT SUDDENLY REACHED ERI AND WAS REPROGRAMMED FROM 000.8 TO VVI. SURGERY FOR DEVICE REPLACEMENT IS PENDING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC PACEMAKER GENERATOR DXY MEDTRONIC, INC 7940 *

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention