BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2930167 · Received January 25, 2013

    Report

    Report Number
    3004209178-2013-00986
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Report Date
    January 7, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3550-02, LOT# N146644, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    A POWER ON RESET (POR) CONDITION WAS REPORTED. UNFORTUNATELY, THE POR WAS CLEARED BEFORE THE ERROR CODE WAS TAKEN NOTE OF. AS SUCH, THE CODE WAS NOT AVAILABLE. THE REPORTER STATED THAT THE PATIENT DID NOT RECALL ANY EVENT OR EXPOSURE THAT MIGHT HAVE CORRELATED TO THE ONSET OF THE POR CONDITION. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT OVERDISCHARGED AS THE PATIENT HAD ¾ OF A CHARGE IN HER BATTERY. IMPEDANCES WERE RUN WHICH SHOWED EACH ELECTRODE WAS WITHIN NORMAL LIMITS. IT WAS UNCLEAR WHAT CAUSED THE POR. HOWEVER, AFTER CLEARING THE POR, THE PATIENT WAS RECEIVING SATISFACTORY STIMULATION AND FELT THAT THERAPY WAS EFFECTIVE. THE PATIENT WAS ASKED TO FOLLOW-UP SHOULD A POR OCCUR AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35165 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