BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3062736 · Received April 17, 2013

    Report

    Report Number
    3004209178-2013-06419
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Report Date
    March 22, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3550-39, LOT# N331050, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY; PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD TO INCREASE THE AMPLITUDE OF THEIR STIMULATION DURING STORMS WHICH CAUSED PAIN IN THEIR RIBS. IT WAS ADDED THE PATIENT STILL HAD PAIN IN BOTH THE LEGS AND UPPER BACK EVEN THOUGH THE AMPLITUDE WAS UP HIGH WHEN THE WEATHER GOT REALLY BAD. IT WAS REPORTED THE PATIENT EXPERIENCED 'JUST A LITTLE BIT' OF PAIN ON THE TOP OF THE STIMULATOR WHEN THE STORMS WEREN'T BAD. THE PATIENT STATED 'THE STIMULATION WORKED PRETTY GOOD BUT IT DIDN'T COVER EVERYTHING.' IT WAS STATED THE STIMULATION WORKED UP UNTIL THE PATIENT FELL ON SOME SNOW AND ICE THIS PAST WINTER. IT WAS ALSO STATED THE PATIENT'S PAIN HAD 'BEEN GETTING WORSE AND NOW HE JUST CAN'T STAND IT AND THAT IS WHY HE IS GOING IN NEXT WEEK TO BE EVALUATED.' IT WAS NOTED THE PATIENT'S STIMULATION HAD GOTTEN TO THE POINT WHERE IT HURT HIS RIBS AND HE HAD TO TURN IT DOWN AND JUST TOLERATE THE PAIN IN HIS LEGS AND BACK. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166257 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