BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4221360 · Received November 3, 2014

    Report

    Report Number
    3007566237-2014-03205
    Event Type
    Injury
    Date Received
    November 3, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CALLER HEARD OF PATIENT THAT HAD AN IMPLANTABLE NEUROSTIMULATOR (INS) THAT TORE UP THE PATIENT¿S LIGAMENTS AND NERVES. THE INS WAS WEARING OUT HIS LIGAMENTS AND ¿IT WAS HANGING ON AND HIS NERVES.¿ THE PATIENT HAD THE INS FOR OVER 12 YEARS AND HE WAS TRYING TO GET RID OF IT. THE PATIENT WAS IN THE HOSPITAL TRYING TO GET A REFERRAL TO HAVE THE SPINAL CORD STIMULATOR (SCS) REMOVED. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. ADDITIONAL INFORMATION COULD NOT BE 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
    701253 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other