BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3295231 · Received August 19, 2013

    Report

    Report Number
    3004209178-2013-14784
    Event Type
    Malfunction
    Date Received
    August 19, 2013
    Report Date
    July 22, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 377760, LOT# V000402, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL (B)(6) 2012 AND HAD NOT BEEN ABLE TO CONNECT THE STIMULATOR TO THE PROGRAMMER OR RECHARGER SINCE THAT TIME. THE PROBLEM MAY HAVE BEEN PRESENT BEFORE THAT TIME, HOWEVER. THE PATIENT COULD ONLY MAKE ADJUSTMENTS WHEN THE ANTENNA WAS ATTACHED. THE STIMULATOR USUALLY HELPED THE PATIENT¿S PAIN AND MADE IT THAT SHE DIDN¿T HAVE TO TAKE AS MANY MEDICATIONS. THE PATIENT REQUESTED ASSISTANCE FOR A PHYSICIAN MODE RESET (PMR) AND WAS DIRECTED BACK TO HER PHYSICIAN. IT WAS FURTHER REPORTED THAT THE PATIENT WANTED TO SPEAK WITH A COMPANY REPRESENTATIVE REGARDING A PAIN PUMP OR POSSIBLY A NON RECHARGEABLE STIMULATOR SINCE THE PAST STIMULATOR DIDN¿T LAST AS LONG. THE PATIENT DIDN¿T LIKE HAVING TO RECHARGE HER DEVICE. IT WAS FURTHER REPORTED THAT THE PATIENT PRESSED A BUTTON AND THOUGHT HER STIMULATION TURNED BACK ON. THE PATIENT THOUGHT SHE WAS FEELING STIMULATION, HOWEVER, AN OVERDISCHARGE (OD) WAS SUSPECTED AS THE PATIENT FELL AND THE STIMULATOR HADN¿T WORKED SINCE. THE LAST SUCCESSFUL RECHARGING SESSION WAS RIGHT BEFORE THE FALL, WHICH IS THE LAST SHE FELT STIMULATION. THE RECHARGER SHOWED THAT THE BATTERY WAS FULL AND THAT SOMETHING WAS BLINKING. THERE WERE NO BOXES AT THE BOTTOM OF THE SCREEN, BUT THE PATIENT NEVER DID SEE BOXES EVEN WHEN THE STIMULATOR WAS WORKING. THE PROGRAMMER DISPLAYED THE POOR COMMUNICATION SCREEN. THE PATIENT WAS REDIRECTED BACK TO THEIR PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401202 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 00074 YR