BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4860004 · Received June 22, 2015

    Report

    Report Number
    3004209178-2015-11994
    Event Type
    Malfunction
    Date Received
    June 22, 2015
    Date of Event
    May 25, 2015
    Report Date
    June 1, 2015
    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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT(S): PRODUCT ID: 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS GETTING AN END OF SERVICE (EOS)/END OF LIFE (EOL) MESSAGE. THE PATIENT STOPPED FEELING STIMULATION ON THE WEEK PRIOR TO REPORT. THE PATIENT FELT IT RESTART AND THEN IT STOPPED. THE PATIENT RECHARGED ON THE SATURDAY PRIOR TO REPORT USING THE ANTENNA LOCATE FEATURE BUT AFTER RECHARGING THE PATIENT WAS NOT ABLE TO START UP STIMULATION. THE PATIENT FELT WEIRD AND SAW EOS. THE PATIENT STATED THAT STIMULATION FELT LIKE IT WAS REAL LOW AND IT FELT WEIRD. THE PATIENT WAS NOT ABLE TO TURN STIMULATION UP OR DOWN. THE PATIENT USUALLY TURNED STIMULATION DOWN AT NIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402759 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