BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2893531 · Received January 2, 2013

    Report

    Report Number
    3004209178-2013-00058
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Report Date
    December 10, 2012
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: PRODUCT ID: 39565-30, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID: 37752, SERIAL#: (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID: 37743, SERIAL#: (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID: 3708140, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION; PRODUCT ID: 3708140, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NOT BEEN ABLE TO FEEL STIMULATION LIKE SHE WAS PRIOR TO A COUPLE OF DAYS BEFORE IT WAS REPORTED. THE PATIENT KEPT STIMULATION AT 3.8V AND TURNED IT UP TO 4.0V BUT WAS NOT ABLE TO FEEL STIMULATION. IT WAS NOTED THAT THE PATIENT WAS ABLE TO FEEL STIMULATION WHEN SHE TIPPED HER HEAD BACK BUT FOR A COUPLE OF DAYS PRIOR TO THE REPORT, SHE WASN'T ABLE TO FEEL STIMULATION WHEN SHE DID THAT. THE REPORTER INDICATED THAT THE PATIENT HAD TO TURN STIMULATION UP PAST 5V OR HIGHER AT NIGHT. HOWEVER, THE PATIENT COULD NOT HAVE STIMULATION ON THAT HIGH DURING THE DAY OR SHE WOULD BE "TRIPPING OVER HER FEET". THE PATIENT HAD TRIED DIFFERENT PROGRAMS AND SETTINGS AS WELL. THERE HAD BEEN NO PATIENT FALLS OR TRAUMA. IT WAS ALSO REPORTED THAT THE PATIENT'S RECHARGING FREQUENCY HAD BEEN "ERRATIC". ABOUT 6 MONTHS BEFORE, THE PATIENT HAD TO CHARGE EVERY OTHER DAY VERSUS EVERY 4TH DAY. IT WAS NOTED THAT THE PATIENT WAS BACK TO CHARGING EVERY 4TH DAY. IT WAS ALSO INDICATED THAT THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION. THE REPORTER INDICATED THAT THE PATIENT SAW AN ERROR MESS AGE ON HER PATIENT PROGRAMMER BUT COULD NOT RECALL WHEN THE MESSAGE WAS. THE ERROR MESSAGE WAS NOT A END-OF-SERVICE (EOS) MESSAGE BUT STARTED WITH A 00. IT WAS NOTED THAT THE PATIENT CHANGED THE BATTERIES IN HER PROGRAMMER AND HAD NOT SEEN THE ERROR CODE SINCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148 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