BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 5308071 · Received December 17, 2015

    Report

    Report Number
    3004209178-2015-25245
    Event Type
    Malfunction
    Date Received
    December 17, 2015
    Date of Event
    November 22, 2015
    Report Date
    November 24, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 97740, SERIAL# (B)(4) , PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4) .

    Description of Event or Problem · 1

    THE MANUFACTURER REPRESENTATIVE REPORTED VIA THE PATIENT THAT WHEN FOLLOWING A RECENT IMPLANT, WHEN TRYING TO SET A NEW AMPLITUDE, IT WOULD NOT TRANSITION/ADJUST WITH THE POSITION (UPRIGHT TO LYING BACK). SHE WAS GETTING INCREASED AMPS AND THE STIMULATION OUTPUT CHANGED UNEXPECTEDLY WHEN MOVING BETWEEN POSITIONS. THE VOLTAGE WAS INCORRECT. THE STIMULATION CUT OUT RANDOMLY WHEN THE PATIENT WAS NOT MOVING; THOUGH, STIMULATION WAS ON. THE PATIENT WOULD SHOW DEVICE LYING DOWN, BUT WHEN SHE SAT UP, IT WOULD NOT ADJUST, ALTHOUGH THE POSITION WAS REFLECTED. ADAPTIVE STIMULATION (AS) WORKED WELL FOR THE THREE DAYS LEADING UP TO THE REPORT. CLINICIAN PROGRAMMER DIAGNOSTICS: THE PATIENT POSITION AND DEVICE WERE ORIENTED, THE PATIENT USED A STRAP TO KEEP THE IMPLANTABLE NEUROSTIMULATOR (INS) IN PLACE, THE TRANSITION SETTINGS WERE SET TO AS LOW AS POSSIBLE AND AS WAS TESTED. THE ACCELEROMETER WAS STILL NOT ADJUSTING FROM UPRIGHT TO LYING BACK. WHILE USING THE PATIENT'S PROGRAMMER, THEY WENT THROUGH MOTIONS AND PROGRAMMER STAYED ON LYING B- DID NOT SWITCH TO LYING L OR LYING R. AFTER SYNC AT EACH POSITION, THE ANTENNA AND PATIENT PROGRAMMER THAT WAS ASSIGNED ON IMPLANT DATE WERE SWITCHED OUT AND ALL WAS RECOGNIZED AND APPROPRIATE AMPS REGISTERED. THE AS AMPLITUDES WORKED AND THE ISSUE WAS RESOLVED. ELECTRODE AND GROUP IMPEDANCES WERE NORMAL. THE INDICATION FOR THERAPY WAS SPINAL PAIN. IF ADDITIONAL INFORMATION IS RECEIVED, THE EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835503 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00034 YR