BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 4103136 · Received September 19, 2014

    Report

    Report Number
    3004209178-2014-17419
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    April 1, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708220, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 3487A-45, LOT # V650017, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3487A-45, LOT # V650017, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3550-39, LOT # N289516, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY; PRODUCT ID 3778-75, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3487A-45, LOT # V650017, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3487A-45, LOT # V650017, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3778-75, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT STOPPED FEELING STIMULATION IN (B)(6) AND MET WITH A COMPANY REPRESENTATIVE AT HER HEALTH CARE PROVIDER¿S (HCP) OFFICE IN (B)(6). THE PATIENT WAS TOLD THAT THERE WAS REPAIR WORK THAT NEEDED TO BE DONE BUT THERE WERE INSURANCE COVERAGE ISSUES. THE PATIENT MET WITH A DOCTOR YESTERDAY WHO DOES NOT SPECIALIZE IN THE DEVICE. THE PATIENT NEEDS TO FIND A DOCTOR THAT WORKS WITH SPINAL CORD STIMULATION (SCS) TO REPAIR HER SYSTEM AND POSSIBLY RELOCATE LOWER SO IT WON¿T STICK OUT SO FAR. BACK IN (B)(6), DIAGNOSTIC TESTS WERE PERFORMED AND THE PATIENT WAS TOLD THAT THERE WAS FLUID IN THE LEADS THAT NEEDED TO BE DRAINED. THE PATIENT HAS A THINNER BODY TYPE AND THE INS PROTRUDES A BIT. THE PATIENT HAS CLIPPED THE DEVICE ON DOOR FRAMES A FEW TIMES AND HER DOG HAS JUMPED ON HER. THE PATIENT HAD A FALL ON A WET KITCHEN FLOOR BUT SHE DID NOT REMEMBER THE DATES OF WHEN THESE EVENTS OCCURRED. THE UNIT HAS MADE A WORLD OF DIFFERENCE IN THE PATIENT¿S LIFE, SINCE A SURGERY PRIOR TO DEVICE IMPLANT, THAT DID NOT GO SO WELL. THE STIMULATION THERAPY WAS ON 24 HOURS A DAY PRIOR TO (B)(6). THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE INS QUIT WORKING, THE PATIENT DID NOT REMEMBER WHEN (SHE DID NOT WRITE IT DOWN). THE PATIENT NOTICED IT WAS INTERMITTENT AND SHE NOTICED A SPIKE IN PAIN. THE DEVICE STOPPED HELPING WITH THE PAIN STARTING IN (B)(6). THE PATIENT HAD WEANED HERSELF OFF OF MEDICATIONS FOR A YEAR AND A HALF. IT WAS NOTED THAT THE FALL HAPPENED (B)(6) 2012, AT THAT TIME THE PATIENT WAS SEEING HER HCP EVERY MONTH AND THEY WOULD READ THE UNIT. THE PATIENT HAS BEEN KEEPING IT CHARGED AND WAS TAKING A LONG TIME TO CHARGE. NORMALLY THE PATIENT GOT 3.5 WEEKS OUT OF IT BUT STARTING IN (B)(6) SHE HAD TO CHARGE EVERY WEEK. THE LAST TIME THE PATIENT SUCCESSFULLY CHARGED WAS A COUPLE OF WEEKS AGO. THE PATIENT STOPPED FEELING STIMULATION IN (B)(6) BUT ON (B)(6), IT WORKED WHILE SHE WAS IN LINE AT THE STORE WHICH STOPPED WHEN SHE GOT OUT OF THE LINE. IT WAS CONFIRMED THAT THE LEADS WERE OPEN CIRCUITS. REPROGRAMMING, BACK IN (B)(6), WAS PERFORMED AT THE PHYSICIAN¿S OFFICE WHICH ACHIEVED THERAPY EFFICACY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582031 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 00047 YR