BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 4243289 · Received November 11, 2014

    Report

    Report Number
    3004209178-2014-21304
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Report Date
    November 3, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER, PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37791, LOT # UNKNOWN, PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STARTING A MONTH AGO, THE PATIENT WOULD GET AN IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR) ANTENNA TOO HOT MESSAGE. THE PATIENT HAD 5 OR MORE COUPLING BARS AND HAD ALMOST BEEN DONE CHARGING AFTER 4-6 HOURS OF CHARGING WHEN THE ANTENNA TOO HOT MESSAGE WOULD APPEAR. THE PATIENT HAD NOT RECEIVED ANY ERROR CODES AND THE ANTENNA TOO HOT MESSAGE DIDN¿T APPEAR RIGHT AWAY, BUT AFTER HAVING CHARGED FOR HOURS. THE PATIENT WOULD HAVE TO CHARGE THE IMPLANTABLE NEUROSTIMULATOR (INS) FOR 4-6 HOURS EVERY 2 DAYS AND WOULD ALWAYS HAVE THE INSR PLUGGED INTO THE WALL WHILE CHARGING. WHEN THE INS NEEDED CHARGING THE PATIENT WOULD CHARGE IT UP, WHICH WAS MORE OF AN ISSUE AS THE PATIENT COULDN¿T CHARGING THE INS FOR 4-6 HOURS AT A TIME EVERY 2 DAYS. THE PATIENT¿S SETTINGS HAD BEEN AT 7.2VOLTS, BUT WERE DECREASED TO 4.8VOLTS IN OCTOBER OF 2014. THE PATIENT HAD KEPT THE INSR IN HIS POCKET UNTIL THE CHARGING WAS COMPLETED, BUT HAD BEEN UNABLE TO DO THAT AT THE TIME OF THIS REPORT. SOMETHING INSIDE OF THE PATIENT WAS BELIEVED TO HAVE MOVED OR WASN¿T ¿RIGHT.¿ THE INS WOULD NOT GIVE THE PATIENT ANY WARNING WHEN IT WAS GOING TO DEPLETE. WHEN THE INS WOULD DEPLETE THE PATIENT¿S PAIN WOULD BE BACK WITHIN A HALF HOUR, THOUGH THE PAIN WAS NOT EXCRUCIATING, BUT WAS ENOUGH TO PROMPT THE PATIENT TO TAKE MORE ME DICATION. THE PATIENT HAD BEEN ¿CUT¿ 7 TIMES AND HAD TEARS DOWN HIS FACE BECAUSE IT WOULD HURT. THE PATIENT HAD HAD A HEALTHCARE PROVIDER (HCP) DO A MYELOGRAM, WHICH HAD BEEN ¿EXCRUCIATING.¿ THE PATIENT HAD HAD A SECOND MYELOGRAM WITHIN THE LAST TWO YEARS. THE PATIENT HAD FELT THAT LAUGHTER WOULD EASE THE PAIN WHILE CRYING WOULD CAUSE MORE PAIN. THE PATIENT WAS BEING SENT A NEW INSR ANTENNA. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725982 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