BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3125489 · Received May 22, 2013

    Report

    Report Number
    3004209178-2013-08061
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Report Date
    May 3, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3550-39, LOT# N191249, IMPLANTED: (B)(6) 2009, PRODUCT TYPE ACCESSORY; PRODUCT ID 3550-29, LOT# N155423, IMPLANTED: (B)(6) 2009, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD JUST MET WITH THE MANUFACTURER REPRESENTATIVE TO HELP RESTART HIS DEVICE. THE PATIENT FORGOT HIS PROGRAMMER, WAS NOW AT HOME, AND WAS UNABLE TO COMMUNICATE WITH THE DEVICE OR MAKE ADJUSTMENTS. IT WAS INDICATED THAT A POR (POWER ON RESET) WAS SHOWING ON THE RECHARGER, BUT NOT THE PROGRAMMER. IT WAS NOTED THAT THE LEADS WERE TESTED AND EVERYTHING WAS OKAY. THE PATIENT WAS UNABLE TO ADJUST WITH THE PROGRAMMER, WAS GETTING THE NO COMMUNICATION SCREEN, HAD TRIED MULTIPLE TIMES, AND THEN IT SEEMED TO WORK. IT WAS NOTED THAT THE PATIENT¿S DEVICE MIGHT BE TOO LOW FOR THE PROGRAMMER TO COMMUNICATE WITH THE DEVICE AND THE PATIENT SHOULD CONTINUE RECHARGING IT.

    Description of Event or Problem · 1

    IT WAS REPORTED ¿THE UNIT HAD GONE OUT.¿ ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227056 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