BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3647443 · Received February 26, 2014

    Report

    Report Number
    3004209178-2014-03608
    Event Type
    Malfunction
    Date Received
    February 26, 2014
    Report Date
    February 5, 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
    CO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: RECHARGER. PRODUCT ID: 3 708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 399930, LOT# V002125, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708340. SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOMEONE HAD STOLEN THE PATIENT¿S ¿MODULATION KIT¿ AND THEY NEEDED A NEW PROGRAMMER. IT WAS ALSO REPORTED THAT THE WHEN THE PATIENT WAS FIRST IMPLANTED THEY TOLD THE PATIENT THAT TO REPLACE THE DEVICE THEY WOULD ¿JUST MAKE AN INCISION, UNSCREW THE SCREWS, AND REPLACE IT LIKE A CAR TIRE¿. IT WAS NOTED THAT THIS WOULD CAUSE PROBLEMS WITH THE PATIENT¿S INSURANCE COMPANY SINCE THEIR IMPLANTABLE NEUROSTIMULATOR (INS) HAD ¿DIED¿ AND WAS NOT WORKING. IT WAS NOTED THAT THE PATIENT USED THEIR INS LAST YEAR AND THEY THOUGHT THEY HAD LAST CHARGED IN THE LAST 12 MONTHS PRIOR TO THE REPORT BUT THEY HAD MEMORY ISSUES AND WERE UNSURE. AN INS OVERDISCHARGE WAS SUSPECTED. THE PATIENT LAST FELT STIMULATION 12 MONTHS PRIOR TO THE REPORT. THE PATIENT WAS ON A ¿PAIN CONTRACT¿ WITH THEIR HEALTH CARE PROVIDER AT THE TIME OF THE REPORT AND COULD BARELY WALK AND WAS IN EXCRUCIATING PAIN ALL THE TIME. THE PATIENT NOTED THAT THEY HAD ONE OVERDISCHARGE AND THOUGHT THAT THEY HAD HAD MORE THAN ONE OVERDISCHARGE OCCURRENCE. IT WAS NOTED THAT THE PATIENT HE HAD MET AT A HOSPITAL BEFORE TO RESET THEIR DEVICE BUT THEY WERE UNSURE WHEN THIS HAPPENED. IT WAS NOTED THAT IT WASN¿T THE EASIEST THING TO DO TO GET A CONNECTION AND RECHARGE AND THEN LAY STILL FOR IT TO CHARGE. THE PATIENT NOTED THAT SOMETIMES THEY WOULD FALL ASLEEP AND THEN WAKE UP AND ONLY HAVE ¼ OF A CHARGE AND WOULD HAVE TO LAY BACK DOWN AND START CHARGING AGAIN. IT WAS NOTED THAT THE PATIENT WOULD FOLLOW UP WITH THEIR DOCTOR TO DISCUSS THEIR OPTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117684 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 Male