BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3773002 · Received April 25, 2014

    Report

    Report Number
    3004209178-2014-08100
    Event Type
    Injury
    Date Received
    April 25, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    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

    PRODUCT ID 37743, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3 550-29, LOT# N153073, IMPLANTED: 2008 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    THE REPLACEMENT WAS SCHEDULED FOR (B)(6) 2014. IT WAS CONFIRMED THAT THE REPLACEMENT WAS COMPLETED AS PLANNED. THE FACILITY REFUSED TO RELEASE THE DEVICE. THE STIMULATION WAS TURNED BACK ON AND THE PATIENT RECEIVED EFFECTIVE THERAPY AFTER SURGERY. THE PATIENT WAS SATISFIED WITH THE COVERAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT TRIED TO CHARGE THEIR IMPLANTABLE NEUROSTIMULATOR (INS) AND STATED THAT THEIR STIMULATION TURNED OFF AND THE RECHARGER DISPLAYED END OF SERVICE (EOS). IT WAS REPORTED, THE BATTERY WAS PREMATURELY DEPLETED AND THE ACTION REQUIRED THE DEVICE TO BE REPLACED. IT WAS REPORTED THE PATIENT HAD PAIN IN THEIR LEFT LEG AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251808 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 00022 YR Required Intervention