BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4111373 · Received September 23, 2014

    Report

    Report Number
    3004209178-2014-17571
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    August 26, 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
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3 550-39, LOT# N293823, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT HAVE CONCERNS WITH THE DEVICE OR THERAPY AND THAT THE DEVICE WAS WORKING WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STIMULATOR DID NOT SEEM TO BE SENDING MESSAGES TO THE RIGHT PLACE. IT WAS NOTED THAT THE PATIENT SYMPTOMS STARTED FOLLOWING A FALL THAT OCCURRED FIVE DAYS PRIOR TO THE REPORT. IN GROUP E, THE PATIENT NO LONGER FELT STIMULATION IN LEFT LEG AND ONLY FELT IT IN THE RIGHT LEG AND BACK. THIS WAS THE PATIENT¿S MAIN CONCERN BECAUSE GROUP E WAS THE GROUP THAT WORKED BEST FOR THE PATIENT. IN GROUP C, THE STIMULATION WORKED DOWN BOTH LEGS. THE PATIENT FELT LIKE THE STIMULATION TURNED OFF EVEN THOUGH THE STIMULATION WAS ON. HE WOULD FEEL IT AND THEN THE STIMULATION WOULD STOP. IT WAS NOTED THAT THE PATIENT SOMETIMES CHANGED THE STIMULATION IN HIS SLEEP AS THE PATIENT WOKE UP HURTING. THE PATIENT STATED THAT SOMETIMES HE ADJUSTED FINE AND SOMETIMES HE DID NOT KNOW WHAT HE WAS DOING. THE PATIENT EXPLAINED THAT HE MAY HAVE CHANGED ONE OF THE SETTINGS AT NIGHT. ON GROUP E, THERE WERE THREE PROGRAMS. AT THE TIME OF THE REPORT, THE PATIENT STARTED PROGRAM 1 AT 3.0V AND IT WAS ADJUSTED. IT WAS FOUND THAT IT AFFECTED THE RIGHT LEG AND THE PATIENT ENDED UP SETTING THIS PROGRAM ON 1.4V. PROGRAM 2 STARTED AT 1 SOMETHING AND WAS ADJUSTED. IT WAS FOUND THAT IT AFFECTED HIS LEFT LEG. THE PATIENT ENDED UP INCREASING TO 4.8 AND MADE FURTHER ADJUSTMENTS BUT STATED HE COULD FEEL STIMULATION ON THE LEFT LEG AGAIN. ON PROGRAM 3, THE PATIENT DID ADJUSTMENTS AND HAD IT AT 4.7V. PROGRAM 3 WAS AFFECTING THE BACK AND RIGHT LEG AND THE PATIENT THOUGHT IT SHOULD ONLY AFFECT THE BACK. IT WAS NOTED THAT SOME STIMULATION SENSATION WAS RESOLVED DURING THE CALL. IT WAS NOTED THAT FOLLOWING A HEMORRHOID SURGERY ON (B)(6) 2014, THE PATIENT TURNED THE STIMULATION DOWN FOR SEVERAL DAYS. THE PATIENT FELT THAT STIMULATION WAS INTERFERING WITH THE HEALING PROCESS. NO INTERVENTIONS OR OUTCOME WERE 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
    589914 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 00056 YR