BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN NEUROMODULATION DEVICE

    MDR report key: 4093393 · Received September 16, 2014

    Report

    Report Number
    3007566237-2014-02596
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    August 22, 2014
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID NEU_STYLET_ACC, SERIAL# UNKNOWN, PRODUCT TYPE: ACCESSORY. (B)(4). ANALYSIS OF THE LEAD (S/N (B)(4)) SHOWED NO ANOMALY FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INTRAOPERATIVE TESTING OF A PERMANENT IMPLANT ON (B)(6) 2014, HIGH IMPEDANCES OF GREATER THAN 40,000 WERE FOUND ON ELECTRODES 12, 13, 14, AND 15. THE PATIENT COULD NOT FEEL ANY STIMULATION AND NEVER RECEIVED THERAPEUTIC EFFECT FROM THOSE ELECTRODES DURING INTRAOPERATIVE TESTING, EVEN AT 10.5 VOLTS. TROUBLESHOOTING WAS PERFORMED INCLUDING: X-RAYS, REPROGRAMMING, AND THE PLACEMENT OF THE LEAD INTO THE TEST CABLE WAS CHECKED SEVERAL TIMES BUT THE ERROR WAS NOT REMEDIED. ONCE A NEW LEAD WAS PLACED EVERYTHING WAS RESOLVED AND A FAULTY LEAD WAS DETERMINED TO BE THE CAUSE OF THE ISSUE. AT THE TIME OF THE REPORT THE PATIENT WAS ALIVE WITH NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571257 UNKNOWN NEUROMODULATION DEVICE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1