BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3113522 · Received May 15, 2013

    Report

    Report Number
    3004209178-2013-07687
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    November 1, 2012
    Report Date
    May 13, 2013
    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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED PAIN IN LEFT BACK, BUTT AND HAMSTRING. LAST YEAR AROUND (B)(6) 2012 HE SAT FOR FOUR HOURS PROGRAMMING HIS DEVICE WITH TWO COMPANY REPRESENTATIVES AND ALL 16 ELECTRODES. THE SIGNAL ON THE LEFT SIDE WAS NOT ABLE TO GET BETTER. HE NOW RECEIVED THE NO COMMUNICATION ICON. HE WAS FEELING STIMULATION BUT COULD NOT MAKE ADJUSTMENTS ON THE PROGRAMMER. NEW BATTERIES WERE PUT IN THE PROGRAMMER. THERE WERE ALSO COUPLING ISSUES BUT IT WAS CLARIFIED THAT THE PATIENT DOES NOT SEEM TO EVER FULLY CHARGE THE INS. IT WAS NOTED HE DOES NOT USE THE BELT WITH RECHARGING. HE CAN USUALLY GET 4-6 BOXES BUT IT ¿TAKES FOREVER¿ FOR IT TO CHARGE. HIS DEVICE WAS BEEN REPROGRAMMED MULTIPLE TIMES AND HE CANNOT ADJUST SETTINGS. HE HAS A LITTLE TILT ON HIS SPINAL CORD. HE HAS THOUGHT ABOUT HAVING THE DEVICE REMOVED BUT DECIDED SOME STIMULATION WAS BETTER THAN NONE. IT WAS LATER REPORTED THAT THE NUMBERS RECEIVED WITH THE ANTENNA LOCATE FEATURE WERE 30-42-42. HE INITIALLY RECEIVED 8 SHADED BARS BUT THEN DROPPED TO 6. HE DOES NOT USE THE BELT DUE TO IT BEING UNCOMFORTABLE. AN X-RAY OF THE PADDLE SHOWED THAT IT WAS TILTED. THE RECHARGING DIFFICULTIES HAVE BEEN PRESENT SINCE IMPLANT. THE PATIENT PROGRAMMER WAS NOT ABLE TO MAKE ADJUSTMENTS WITH THE ANTENNA ATTACHED. NO TELEMETRY WAS POSSIBLE WITH THE ANTENNA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THEIR ANTENNA WAS NOT WORKING WITH THE NEW PATIENT PROGRAMMER. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214297 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR