BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 5172948 · Received October 24, 2015

    Report

    Report Number
    3004209178-2015-21344
    Event Type
    Malfunction
    Date Received
    October 24, 2015
    Report Date
    September 30, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3550-39, LOT# N180082, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. PRODUCT ID 3 9565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED SHE HAD A STROKE, FELL, AND HAD A PELVIC FRACTURE AND WAS IN A LOT OF PAIN. SHE THOUGHT HER "INTERNAL ANTENNA" (IMPLANTED DEVICE COMPONENTS) MAY HAVE MOVED WHEN SHE FELL AND ALSO REPORTED THAT SHE HAD LOST A LOT OF WEIGHT SINCE THE STROKE AS WELL WHICH MIGHT BE CAUSING IT TO MOVE AROUND. IT WAS FURTHER REPORTED WHEN SHE WAS IN REHAB NO ONE MAINTAINED HER IMPLANTABLE NEUROSTIMULATOR (INS) UNIT AND WHEN SHE TRIED TO CHARGE THE INS SHE WASN'T ABLE TO GET THE NORMAL CHARGING SCREEN WITH COUPLING BARS. SHE HADN'T CHARGED SUCCESSFULLY SINCE THE BEGINNING OF SUMMER. RELEVANT MEDICAL HISTORY INCLUDES FAILED BACK SURGERY SYNDROME. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING 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
    703126 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1