BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3770146 · Received April 24, 2014

    Report

    Report Number
    3004209178-2014-08048
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Report Date
    April 3, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3888-45, LOT# V388289, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# V327604, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# V355428, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# V327604, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 37082-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37082-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT FELT THE LEAD HAD BROKEN. IT WAS STATED THAT THERE HAD BEEN NO FALLS OR ACCIDENTS, BUT THE PATIENT NOTICED A WEEK AGO THERE WAS A DIFFERENCE. IT WAS STATED THAT THE CALLER FELT PAIN IN HIS BACK AND STATED IT FELT ¿LIKE A FORK WAS STUCK IN HIS BACK¿. IT WAS NOTED THAT THE LEADS RAN UP HIS BACK TO HIS SKULL. IT WAS REPORTED THAT WHEN HE TURNED UP THE STIMULATOR ON THE RIGHT SIDE HE FELT NOTHING, BUT ON THE LEFT SIDE HE FELT IT AND COULD FEEL IT INCREASING. IT WAS NOTED THAT THE PATIENT DIDN¿T USE HIS IMPLANTABLE NEUROSTIMULATOR (INS) EVERY DAY. IT WAS STATED THAT THE PATIENT HAD HIS WIFE CHECK HIS BACK AND SAID SHE WAS ABLE TO FEEL THE LEAD ON HIS BACK. IT WAS NOTED THAT THE PATIENT HAD TOLD HIS HEALTHCARE PROFESSIONAL WHO HAD REDIRECTED HIM TO CALL THE MANUFACTURER. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD LOSS OF THERAPEUTIC EFFECT AND NO STIMULATION SENSATION ON THE RIGHT SIDE. IT WAS STATED THAT THIS OCCURRED ¿ABOUT TWO WEEKS AGO¿ WHILE THE PATIENT WAS ¿JUST SITTING IN A CHAIR¿ AND FELT A CHANGE IN STIMULATION. IT WAS REPORTED THAT THE CALLER READ >10000 OHMS ON CONTACTS 8, 9, 10, 11, 15. IT WAS STATED THAT THE MANUFACTURER¿S REPRESENTATIVE WAS ABLE TO PROGRAM USING THE 3 GOOD CONTACTS (12, 13, 14) BUT THAT THIS DIDN¿T GIVE THE PATIENT AS GOOD OF COVERAGE AS BEFORE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS DOING WELL POST REPROGRAMMING. IT WAS REPORTED THAT NO FURTHER INTERVENTION WAS PLANNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248734 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 00055 YR