BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATORS

    MDR report key: 3202979 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-02199
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 10, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SEVERAL NERVE STIMULATORS WHICH HAD MIGRATED. THE PATIENT HAD SEVERAL DEVICES REMOVED AND RE-IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302932 UNKNOWN IMPLANTABLE NEUROSTIMULATORS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention