BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2772384 · Received October 4, 2012

    Report

    Report Number
    3007566237-2012-02386
    Event Type
    Injury
    Date Received
    October 4, 2012
    Report Date
    September 7, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. PRODUCT ID NEU_UNKNOWN_LEAD, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. PRODUCT ID 37742, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS GOING TO HAVE A REVISION ON (B)(6) 2012. THE PATIENT HAD A LOT OF SCAR TISSUE AND KELOID TISSUE WITH SURGERIES AND WAS PLANNING ON RECEIVING RADIATION THERAPY. THE PHYSICIAN WAS PLANNING ON MOVING THE IMPLANTABLE NEUROSTIMULATOR TO BELOW THE INCISION TO HELP GET THE NEUROSTIMULATOR OUT OF THE FIELD OF RADIATION. THE PATIENT WAS ALSO GOING TO BE UPGRADED TO A RESTORE ULTRA IMPLANTABLE NEUROSTIMULATOR DUE TO SIZE REASONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO MALFUNCTIONS SEEN WITH THE DEVICE. IT WAS FURTHER REPORTED THAT THE PATIENT RECEIVED A ONETIME DOSE OF RADIATION AT THE INCISION SITE DUE TO A PAST HISTORY OF DEVELOPING KELOID TISSUE. THE PATIENT WAS REPORTEDLY RECEIVING THERAPEUTIC BENEFIT AS OF THE POST-OPERATION VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention