BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2993288 · Received March 7, 2013

    Report

    Report Number
    3004209178-2013-03460
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 15, 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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S DEVICE SHUT COMPLETELY OFF THE NIGHT BEFORE THE CALL AND FELT NO STIMULATION. IT WAS NOTED THE PATIENT HAD FALLEN A COUPLE OF WEEKS PRIOR TO THE CALL. IT WAS REPORTED THE PATIENT NORMALLY GOT COVERAGE IN THEIR LEGS AND FEET. IT WAS NOTED THE PATIENT¿S FEET HAD BEEN HURTING A LOT AND SWELLING. IT WAS REPORTED THE PATIENT¿S DEVICE MOVED SLIGHTLY IN THE POCKET EVERY ONCE IN A WHILE.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2013 THAT THERE WAS A LOSS OF STIMULATION. IT WAS STATED THAT THE PATIENT HAD STIMULATION ON ALL OF THE TIME AND COULD FEEL IT BEFORE GOING TO BED LAST NIGHT (DAY BEFORE REPORT) BUT SHE COULDN'T TURN IT ON TODAY (DAY OF REPORT). IT WAS STATED THAT WHEN SHE TRIED THE ANTENNA LOCATE FEATURE, SHE KEPT GETTING THE REPOSITION ANTENNA MESSAGE. THE LAST RECHARGE SESSION WAS 7-8 DAYS AGO. LATER THAT DAY IT WAS REPORTED THAT THE PATIENT HAD RETURN OF SYMPTOMS SINCE ABOUT A MONTH AGO. IT WAS STATED THAT THE PATIENT 'FELL ON' HER IMPLANTABLE NEUROSTIMULATOR (INS) ABOUT A MONTH AGO, BUT DID NOT SEE ANY IMMEDIATE CHANGES FOLLOWING THE FALL. IT WAS STATED THAT THE BATTERY WAS AT 50% WHEN THE PATIENT WENT TO BED LAST NIGHT (DAY BEFORE REPORT). IT WAS NOTED THAT SHE GOT A POOR COMMUNICATION SCREEN WITH OR WITHOUT THE ANTENNA ATTACHED, FOLLOWED BY A 'CALL YOUR DOCTOR' ICON. ON THE SECOND ANTENNA LOCATE FEATURE ATTEMPT, THE PATIENT REPORTED SEEING A POWER ON RESET (POR) MESSAGE. IT WAS STATED THAT THE INS CHARGING STATUS SCREEN HAD ALL 8 COUPLING BARS AND HALF OF THE INS BATTERY FLASHING. THE PATIENT WAS REDIRECTED TO HER HEALTHCARE PROVIDER, AND HAD AN APPOINTMENT WITH HER REPRESENTATIVE ON (B)(6) 2013. IT WAS REPORTED ON (B)(6) 2013 THERE WAS AN OVERDISCHARGE. THE REPRESENTATIVE STATED THE POR MESSAGE WAS CLEARED AND THE PATIENT WAS NOW RECEIVING THERAPEUTIC STIMULATION. IT WAS STATED THAT IT TAKES THE PATIENT LONGER TO RECHARGE HER DEVICE THAN IT USED TO. PATIENT RECOVERED WITHOUT SEQUELA. IF FURTHER INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97115 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 53 YR