BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3102718 · Received May 9, 2013

    Report

    Report Number
    3004209178-2013-07442
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 18, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37092, LOT# 253500001, IMPLANTED: (B)(6) 2010, PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE STIMULATOR ¿DOES NOT WORK.¿ IT WAS NOTED THE STIMULATOR WAS NOW DEAD BECAUSE THE PATIENT WAS UNABLE TO CHARGE THEIR DEVICE. IT WAS NOTED THE PATIENT HAD HAD TROUBLE RECHARGING SINCE IMPLANT. THE PATIENT WAS TOLD THEY WOULD NEED A SURGERY TO MOVE THE STIMULATOR IN 2011. NOW THE PATIENT HAS ANOTHER HEALTH ISSUE AND NEEDS AN MRI AND WOULD LIKE THEIR DEVICE REMOVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS NO LONGER FUNCTIONING. IT WAS NOTED THAT THE PATIENT WANTED THE DEVICE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203471 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