BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3103248 · Received May 9, 2013

    Report

    Report Number
    3004209178-2013-07473
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 16, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE RECHARGER; PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 3888-33, LOT# V000051, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 3888-33, LOT# V000844, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S STIMULATION WAS TURNING OFF BY ITSELF. THREE DAYS PRIOR TO THIS REPORT THE PATIENT WOKE UP WITH PAIN IN HER LEFT LEG; SHE CHECKED HER IMPLANTABLE NEUROSTIMULATOR (INS) WITH HER PROGRAMMER AND ENDED UP TURNING STIMULATION BACK ON. THE PATIENT¿S PAIN GOT BETTER ONCE STIMULATION WAS BACK ON. IT WAS REPORTED THE MORNING OF THIS REPORT THE PATIENT¿S INS DID THE SAME THING AND TURNED OFF AUTOMATICALLY. IT WAS NOTED WHEN THE PATIENT CHECKS STIMULATION SHE PRESSES THE STIMULATION 'ON' BUTTON WITH HER PATIENT PROGRAMMER. IT WAS ALSO NOTED THE PATIENT USUALLY CHECKED HER INS WITH HER PROGRAMMER ABOUT ONE TIME A WEEK. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT RECEIVED ASSISTANCE FROM A MANUFACTURER REPRESENTATIVE AND HER CONCERNS WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202743 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 00085 YR