BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3223685 · Received July 12, 2013

    Report

    Report Number
    3004209178-2013-11675
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 21, 2013
    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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3998, LOT# V246530, IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD: PRODUCT ID 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A VERY DIFFICULT TIME CONNECTING TO THE IMPLANTABLE NEUROSTIMULATOR (INS) AND ¿HARDLY EVER¿ ACQUIRED ANY COUPLING BOXES. IT WAS NOTED THAT THE PATIENT ¿HAD SOME WEIGHT TO WORK WITH.¿ IT WAS NOTED THAT THE PATIENT KNEW THE STIMULATION WAS WORKING BECAUSE HE FELT A ¿SHOCKING¿ SENSATION IN THE NECK. IT WAS FURTHER NOTED THE PATIENT NOTICED THE INS BATTERY WAS EMPTY AND PUT IN NEW BATTERIES IN THE PATIENT PROGRAMMER. BASIC FUNCTIONALITY OF THE DEVICE WAS REVIEWED. IT WAS NOTED THAT THE PATIENT CONFIRMED THAT THE INS WAS ¿ALMOST EMPTY.¿ ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322910 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 00055 YR