BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2934644 · Received January 30, 2013

    Report

    Report Number
    3004209178-2013-01106
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Report Date
    January 9, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 377875, LOT# V013122, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3550-39, LOT# N243742, IMPLANTED: (B)(6) 2010, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, AFTER A PATIENT HAD CHARGED HER DEVICE, PATIENT PROGRAMMER SHOWED "ICONS LIKE IT WASN'T COMMUNICATING." BATTERIES WERE CHANGED AND SAME ISSUE OCCURRED. THIS ALSO OCCURRED ON RECHARGER AS WELL. EVENTUALLY, "LIGHTNING BOLT" AND ON STATUS WERE SEEN, THE DEVICE WAS TURNED OFF AND "LIGHTNING BOLT" WENT AWAY, BUT IT WAS CLAIMED THAT THE PATIENT STILL FELT STIMULATION. THE PATIENT WAS AT A COMFORTABLE LEVEL AT THE TIME OF THE REPORT, SO IT WASN'T "A BIG DEAL." THE PATIENT HAD NOT BEEN IN OVERDISCHARGE RECENTLY. THIS EVENT JUST HAPPENED THE NIGHT PRIOR TO THE REPORT, NO OTHER KNOWN EVENTS FOR THIS CASE HAD HAPPENED. IT WAS ALSO REPORTED THAT IT WASN'T POSSIBLE TO ADJUST STIMULATION. IT WAS STATED THAT THE DISPLAY SHOWED "IN THE BOX" ICON. IT WAS STATED THAT THE PATIENT USED ANTENNA LOCATE (AL) FEATURE EVERY TIME SHE CHARGED HER IMPLANTABLE NEUROSTIMULATOR (INS). THE INS RECHARGER (INSR) WAS THEN USED AND IT WENT TO THE NORMAL CHARGING SCREEN SHOWING INS WAS ON WITH 8 COUPLING BARS SEEN. IT WAS ADVISED NOT TO USE AL ALL THE TIME BUT ONLY FOR WHEN THE PATIENT WAS HAVING TROUBLES WITH GETTING COUPLING. ONE DAY LATER IT WAS REPORTED THAT IT WAS CLEARED WITH THE PROGRAMMER AND IT DID SHOW THE BATTERY WAS ON. IT WAS STATED THAT EVERYTHING WAS COMMUNICATING PROPERLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40835 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