BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 5071285 · Received September 11, 2015

    Report

    Report Number
    3004209178-2015-17833
    Event Type
    Malfunction
    Date Received
    September 11, 2015
    Report Date
    August 17, 2015
    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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3998, LOT# V042627, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED A SUDDEN RETURN OF SYMPTOMS AND LOSS OF THERAPY WHICH LED TO THEM HURTING AND IN PAIN FOR A WEEK. EVERY JOINT WAS HURTING AND IT HURT IN THEIR SPINE FROM THEIR ARTHRITIS. UNTIL THE LOSS OF THERAPY THEIR DEVICE HAD WORKED "BEAUTIFULLY." PRIOR TO CALLING IN THE PATIENT NOTED THAT THE BATTERIES IN THEIR PATIENT PROGRAMMER WERE DEAD SO THEY REPLACED THEM BUT WERE THEN UNABLE TO CHANGE TO GROUP B TO INCREASE THEIR STIMULATION. GROUP B WOULD NOT EVEN COME UP ON THE SCREEN AT ALL AND ANY TIME THEY TRIED TO INCREASE IN GROUP B THE PATIENT PROGRAMMER WOULD CUT OFF. IT WAS FOUND WHILE ON THE CALL THAT THE SCREEN WAS SHOWING "TURN INS ON "WHEN TRYING TO INCREASE AND DETERMINED THAT THE PATIENT'S DEVICE WAS OFF WHICH WAS WHY THEY COULD NOT TURN IT UP. THE PATIENT WAS ABLE TO TURN THE DEVICE ON AND GOT TO PROGRAM A WHICH SHOWED 1.20V. THEY SWITCHED TO GROUP B, SYNCED AND WAS SUCCESSFULLY ABLE TO INCREASE THE STIMULATION. THE PATIENT PROGRAMMER WAS NOTED TO BE WORKING AS INTENDED. THE PATIENT REALIZED THE THERAPY HAD BEEN OFF WHEN IT WAS DISCOVERED ON THE PHONE CALL AND DID NOT KNOW IT WAS OFF PRIOR TO CALLING IN. THE INDICATION FOR USE WAS FOR DEGENERATIVE DISC DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603636 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR