BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2364751 · Received December 9, 2011

    Report

    Report Number
    3004209178-2011-09699
    Event Type
    Malfunction
    Date Received
    December 9, 2011
    Date of Event
    November 1, 2011
    Report Date
    November 12, 2021
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: LEAD MODEL 3888 LOT # V124517 IMPLANTED: UNK EXPLANTED: UNK; LEAD MODEL 3888 LOT # V121154 IMPLANTED: UNK EXPLANTED: UNK; RECHARGER MODEL 37752 SERIAL # (B)(4) IMPLANTED: NA EXPLANTED: NA; EXTENSION MODEL 37082 SERIAL # (B)(4) IMPLANTED: UNK EXPLANTED: UNK; EXTENSION MODEL 37082 SERIAL # (B)(4) IMPLANTED: UNK EXPLANTED: UNK; PATIENT PROGRAMMER MODEL 37743 SERIAL # (B)(4) IMPLANTED: NA EXPLANTED: NA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NOT CHARGED THEIR DEVICE FOR "MONTHS AND MONTHS." AN OVERDISCHARGE WAS CONFIRMED. THE PATIENT LET THE DEVICE GO INTO AN OVERDISCHARGE BECAUSE SHE STATED SHE WAS NOT ABLE TO RECHARGE PROPERLY AND JUST GOT "SICK OF IT" EVEN THOUGH THE THERAPY WAS BENEFICIAL. THE PATIENT WAS UNABLE TO BRING THE BATTERY BACK TO LIFE AND WAS CONSIDERING A REPLACEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female