BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3122711 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-07991
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    May 2, 2013
    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

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FOUND THAT ALONG WITH THE COMMUNICATION PROBLEM WITH THEIR RECHARGER, POWER ON RESET AND REPOSITION ANTENNA MESSAGE ON THEIR SCREEN, A DISCHARGE OR OVERDISCHARGE WAS ALSO SUSPECTED AND A "CALL YOUR DOCTOR" ICON APPEARED. ADDITIONAL INFORMATION ALSO FOUND THAT THE PATIENT HAD DIFFICULTIES RECHARGING THEIR STIMULATOR. AFTER TROUBLESHOOTING THE PATIENT WAS ABLE TO RECEIVE A NORMAL RECHARGING SCREEN. NO PATIENT SYMPTOMS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A COMMUNICATION PROBLEM WITH THEIR RECHARGER AND WHEN THEY ATTEMPTED TO RECHARGE THEIR IMPLANTABLE N EUROSTIMULATOR (INS) THEY RECEIVED A REPOSITION ANTENNA MESSAGE ON THEIR SCREEN. IT WAS NOTED THE PATIENT HAD NOT HAD ANY CHANGES TO THEIR INS POCKET SITE AND THERE WERE NO FALLS OR TRAUMAS. IT WAS STATED THE LAST TIME THE PATIENT SUCCESSFULLY RECHARGED THEIR DEVICE WAS ONE MONTH PRIOR TO REPORT. REPORTEDLY, THE PATIENT¿S USE OF THE ANTENNA LOCATE FEATURE RESULTED IN A POWER-ON RESET (POR) MESSAGE BEING DISPLAYED ON THEIR RECHARGER WHICH THEN LEAD TO THE NORMAL RECHARGING SCREEN. IT WAS NOTED THE PATIENT WAS ABLE TO GET 8 COUPLING BARS. THE PATIENT WAS ADVISED TO RECHARGE THEIR DEVICE TO AT LEAST 50 PERCENT PRIOR TO ATTEMPTING TO CLEAR THE POR MESSAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224742 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 00052 YR