BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3897102 · Received June 26, 2014

    Report

    Report Number
    3004209178-2014-12098
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Report Date
    June 6, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: RECHARGER; PRODUCT ID 3 708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3487A-33, LOT# J0454259V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT FELL ABOUT A YEAR AGO ON THEIR BASEMENT STEPS AND STIMULATION CHANGED SINCE THAT FALL. IT WAS NOTED THE PATIENT ALSO FELL LAST WINTER WHICH MADE IT WORSE. THE REPORTER STATED THEIR BODY HAD TO BE STRAIGHT TO HAVE THERAPY AND IT HURT A LOT WHEN THEY WALK. THE REPORTER FURTHER STATED THEY MAINLY NEED STIMULATION FOR THEIR LEFT LEG. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374676 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR