BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL

    MDR report key: 1851182 · Received September 30, 2010

    Report

    Report Number
    3007566237-2010-07504
    Event Type
    Injury
    Date Received
    September 30, 2010
    Date of Event
    January 1, 2010
    Report Date
    June 22, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FINAL ANALYSIS REVEALED THAT THE LEAD WITH (B)(4) HAD NO ANOMALY AND WAS FUNCTIONING NORMALLY. ANALYSIS OF LEAD WITH (B)(4) INDICATED THAT THE #3, 5 AND 6 CONDUCTORS WERE BROKEN AT THE DISTAL EDGE OF THE #3 CONNECTOR SLEEVE, 1.3 CM FROM THE PROXIMAL END. THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MANUFACTURER EMPLOYEE. A PROCESS IMPROVEMENT PLAN AND TRAINING ARE IN PLACE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A PROBLEM WITH HER NEUROSTIMULATOR. A FEW MONTHS AFTER IMPLANT, "THE PATIENT'S STIMULATION CHANGED." ONE OF THE LEADS HAD OUT-OF-RANGE IMPEDANCES AND THE OTHER LEAD WAS PRODUCING "UNCOMFORTABLE STIMULATION IN THE WRONG AREA." A REVISION WAS PERFORMED IN WHICH BOTH LEADS WERE REPLACED. DURING THE REVISION, AN X-RAY INDICATED THAT ONE OF THE LEADS "APPEARED TO HAVE SLIGHTLY MIGRATED." IT WAS REPORTED THAT THE PATIENT WAS "DOING WELL POST-OP AND RECEIVING GOOD STIMULATION." 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 LGW MEDTRONIC NEUROMODULATION IPG NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| LEAD: MODEL 3877, LOT# B0933821K| LEAD: MODEL 3877, LOT# B0933820K| IMPLANTED:| EXPLANTED:| IMPLANTED: