BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 1181769 · Received September 30, 2008

    Report

    Report Number
    3004209178-2008-06229
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    June 11, 2008
    Report Date
    September 5, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE STIMULATOR REVEALED NO ANOMALY FOUND - IMPLANTABLE NEUROSTIMULATOR IS FUNCTIONALLY OKAY. FINAL DEVICE ANALYSIS OF THE EXTENSION REVEALED NO SIGNIFICANT ANOMALIES - EXTENSION OKAY BUT CUT THRU (SUSPECT EXPLANT DAMAGE). FINAL DEVICE ANALYSIS OF THE LEAD REVEALED A RELIABILITY NON-CONFORMANCE - BROKEN CONDUCTORS IN THE BODY OF THE LEAD (ANCHOR SITE UNKNOWN). ALL/MULTIPLE CONDUCTORS/WIRES WERE BROKEN 13.1 CM FROM THE DISTAL END AND THE OUTER INSULATION WAS PINCHED. THE DISTAL END OF THE PROXIMAL END WERE INTACT AND UNDAMAGED. SUSPECTED BODY FLUIDS OBSERVED IN THE LEAD, BUT HAD NO IMPACT ON LEAD PERFORMANCE.

    Description of Event or Problem · 1

    THE STIMULATOR, LEAD, AND EXTENSION WERE RETURNED TO THE MANUFACTURER. THE RETURN PAPERWORK DID NOT SUGGEST OR QUESTION A MALFUNCTION AND NO PATIENT SYMPTOMS WERE REPORTED. THE DEVICES UNDERWENT ROUTINE ANALYSIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 63 YR EXPLANTED:| EXTENSION: MODEL 7495| PROGRAMMER: MODEL 7434A| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3890| EXPLANTED: