BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3811411 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-08984
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    April 24, 2014
    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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3550-39, LOT # N231555, IMPLANTED: (B)(6) 2009, PRODUCT TYPE ACCESSORY; PRODUCT ID 3778-60, SERIAL # (B)(4) , IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL # (B)(4) , IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4) .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THAT ¿ALL OF A SUDDEN¿ THE PATIENT¿S STIMULATION JUST SHUT OFF. IT WAS NOTED THAT THE PATIENT USUALLY CHARGES EVERY THREE DAYS BUT THEY HAD BEEN HAVING FAMILY ISSUES AND DID NOT GET IT DONE. THE PATIENT REPORTEDLY USED THEIR STIMULATION THERAPY ALL THE TIME, SO IT WAS ¿QUITE A JOLT¿ WHEN IT SHUT OFF. IT WAS NOTED THAT AT THE TIME OF THE REPORT THE PATIENT¿S LEGS WERE ¿LIKE RUBBER¿ AND WHEN IT TURNED OFF IT ¿FELT REALLY FUNNY.¿ IT WAS ALSO NOTED THAT THE PORTABLE ONE DID NOT WORK FOR THE PATIENT. THE PATIENT WAS REPORTEDLY GOING TO SEE IF THEY COULD CHARGE. THE PATIENT REPORTEDLY THOUGHT THAT IT NEEDED TO BE REPROGRAMMED AND WAS CONCERNED THAT THEIR STIMULATOR WOULD NOT BE ABLE TO BE RESTARTED AND HOPED SHE WOULD NOT HAVE TO HAVE SURGERY TO REPLACE IT. IT WAS NOTED THAT THE PATIENT HAD NEVER LET THEIR IMPLANTABLE NEUROSTIMULATOR (INS) LOOSE CHARGE BEFORE. IT WAS NOTED THAT THE PATIENT REPOSITIONED SEVERAL TIMES AND REPORTED GETTING 2, 4, OR 6 BLACK BOXES BUT REPORTEDLY LOST BOXES EASILY TOO. IT WAS NOTED THAT THE PATIENT HAD LOST WEIGHT AND IT SLIPS AROUND. THE PATIENT REPORTEDLY STARTED RECHARGING AND WAS SEEING THE INS ICON WITH AN EMPTY BATTERY, BUT IT WAS BLINKING. THE PATIENT TRIED TO START STIMULATION AND REPORTED THAT THEY FELT IT BUT IT WAS FAINT. THE PATIENT TURNED THE DEVICE OFF UNTIL THE INS HAD A LITTLE MORE CHARGE. AFTER APPROXIMATELY 10 MINUTES OF CHARGING THE INS ICON REPORTEDLY WAS BLINKING BETWEEN 0 AND ¼ FULL. THE PATIENT REPORTEDLY TRIED TO TURN STIMULATION BACK ON AND FELT STIMULATION TOO STRONG. IT WAS RECOMMENDED THAT THE DEVICE BE TURNED BACK OFF UNTIL THE INS WAS FULL ENOUGH TO DISCONNECT FROM THE RECHARGER AND THEN USE THE PATIENT PROGRAMMER TO TURN STIMULATION ON AND ADJUST IT SO THAT IT WOULD NOT BE TOO STRONG. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290115 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR