BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 1162106 · Received September 16, 2008

    Report

    Report Number
    3004209178-2008-05789
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    February 26, 2008
    Report Date
    August 20, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE STIMULATOR WAS RETURNED FOR ANALYSIS. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT SLIPPED ON THE ICE AND FELL. FOLLOWING THE FALL THE PT EXPERIENCED SHOCKING OR JOLTING THEN MINIMAL STIMULATION. MOVEMENT DID NOT CAUSE STIMULATION CHANGES. THE STATUS LIGHTS WERE ASSESSED. WHEN TURNING THE STIMULATOR (INS) ON ALL THE LIGHTS WERE SOLID. WHEN TURNING THE THERAPY OFF, THE TOP LIGHT WAS SOLID, THE MIDDLE (INS) AND BOTTOM (9V) LIGHT WERE FLASHING, SUGGESTING LOW INS AND 9V BATTERY. THE PT'S STIMULATOR WAS LATER EXPLANTED. NO PT OUTCOME WAS REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXTENSION MODEL 7489 LOT# NHU011709V IMPLANTED| LEAD MODEL 3487A LOT# J0327053V IMPLANTED| EXPLANTED| EXPLANTED| PROGRAMMER MODEL 7434A LOT# NGL023511P