BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4274025 · Received November 24, 2014

    Report

    Report Number
    3004209178-2014-22104
    Event Type
    Malfunction
    Date Received
    November 24, 2014
    Date of Event
    November 10, 2011
    Report Date
    November 4, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3998, LOT# V855145, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3550-29, LOT# N293627, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WANTED TO ADJUST STIMULATION FOR HIS PAIN. WHEN HE WOULD INCREASE STIMULATION TOO MUCH HE WOULD FEEL BURNING IN HIS LEGS. IT WOULD GO AWAY IF HE TURNED STIMULATION BACK DOWN. WHEN THE PATIENT¿S PAIN GOT BAD THE IMPLANTABLE NEUROSTIMULATOR (INS) WOULDN¿T HELP AND SOMETIMES WOULD MAKE IT WORSE. A SURGING FEELING WAS EXPERIENCED BEFORE AND HE WOULD LIKE TO GET THAT FEELING BACK. THIS WAS DESCRIBED AS A ¿VROOM VROOM¿ FEELING. STIMULATION ADJUSTMENTS WERE REVIEWED. IT WAS STATED THAT THE PATIENT HAD BEEN IN EXCRUCIATING PAIN AND THE STIMULATOR WASN¿T TOUCHING THE PAIN IN HIS LOWER BACK AND ALL THE WAY DOWN HIS RIGHT LEG. IT WAS NOTED THAT THIS WAS THE PAIN THAT THE DEVICE WAS IMPLANTED FOR. IT HADN¿T HELPED WITH HIS HIGH PAINS SINCE IMPLANT. AFTER MAKING ADJUSTMENTS, THE STIMULATION WAS STAYING ON THE RIGHT SIDE A LITTLE BETTER THAN BEFORE, BUT HE STILL WANTED TO DO FURTHER REPROGRAMMING. FOLLOW-UP WAS CONDUCTED BUT THE HEALTHCARE PROVIDER DID NOT HAVE THE PATIENT REGISTERED AS A PATIENT. FURTHER FOLLOW-UP WAS PERFORMED TO DETERMINE IF THE PATIENT HAD RECEIVED ANY FURTHER ASSISTANCE FOR REPROGRAMMING AND IF THEY HAD ANY FURTHER CONCERNS. THIS EVENT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761344 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 00045 YR