BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3943827 · Received July 18, 2014

    Report

    Report Number
    3007566237-2014-02006
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 26, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY BECAUSE THEIR LEADS MIGRATED AND THE PATIENT NEEDED A PADDLE LAMINECTOMY LEAD INSTEAD. THE PATIENT HAD BEEN VERY HAPPY WITH THEIR DEVICE. BEFORE THE LEADS MIGRATED THE PATIENT HAD BEEN GETTING 60-75% PAIN RELIEF. THE LAMINECTOMY SURGERY WAS 2 WEEKS PRIOR TO THE REPORT. THE PATIENT JUST TURNED THEIR STIMULATION BACK ON TWO DAYS PRIOR TO THE REPORT. THEY WOULD NOT BE ABLE TO FULLY ADJUST AND TWEAK THEIR SETTINGS UNTIL THE SWELLING WENT DOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422065 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention