BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3971749 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-13785
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 11, 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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 377760, LOT# J0546520V, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 377760, LOT# V003344, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DAY PRIOR TO THE REPORT THE PATIENT WAS WALKING AND SUDDENLY THEIR LEG MUSCLES FELT LIKE THEY WERE HAVING SPASMS AND THEY COULD HARDLY BEND THEIR LEG. THE NIGHT PRIOR TO THE REPORT THE PATIENT ROLLED OVER AND FELT A POP IN THEIR BACK AND THE SPASMS GOT WORSE. AFTER THAT THE SPASM INTENSIFIED SO THEY TURNED THE STIMULATION OFF AND WAS STILL FEELING IT ABOVE THEIR KNEES. THE PATIENT HAD NOT HAD ANY FALLS OR ACCIDENTS. IT WAS FURTHER REPORTED THAT THE PATIENT¿S THERAPY WAS NOT WORKING AS EXPECTED. IT WAS FURTHER REPORTED THAT A MANUFACTURER REPRESENTATIVE WAS GOING TO SEE THE PATIENT THE DAY AFTER THE REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448571 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR