BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3113640 · Received May 15, 2013

    Report

    Report Number
    3004209178-2013-07698
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Report Date
    April 23, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3487A-45, LOT# V472477, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3487A-45, LOT# V474739, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3776-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A COMMUNICATION PROBLEM. HE LAST RECHARGED A WEEK AGO BUT THEN WAS STATED HE LOST TRACK OF TIME AND THAT IT COULD HAVE BEEN LONGER. THE USE OF THE ANTENNA LOCATE FEATURE RESULTED IN A POWER ON RESET (POR) BEING DISPLAYED ON THE RECHARGER WHICH THEN LEAD TO THE NORMAL RECHARGING SCREEN. HE WAS NOT ABLE TO ADJUST STIMULATION WITH HIS PATIENT PROGRAMMER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214756 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