BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4240312 · Received November 10, 2014

    Report

    Report Number
    3007566237-2014-03272
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37081, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. PRODUCT ID: 3777, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: 97791, SERIAL# UNKNOWN, PRODUCT TYPE: ACCESSORY. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD FOUND THE CONDUCTOR WAS BROKEN AT THE INJEX ANCHOR SITE. ALL CONDUCTORS WERE BROKEN 22 CM FROM THE DISTAL END. ANALYSIS OF THE EXTENSION FOUND THE CONDUCTOR WAS BROKEN WITHIN 10 CM OF CONNECTOR AREA. THE #2 CONDUCTOR WAS BROKEN 2.9 CM FROM THE PROXIMAL END.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS NOT RECEIVING BENEFICIAL STIMULATION AND THE LEAD HAD HIGH IMPEDANCES. THE PROBLEM HAD OCCURRED PREOPERATIVE. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722328 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1