BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3388636 · Received October 4, 2013

    Report

    Report Number
    3004209178-2013-17526
    Event Type
    Malfunction
    Date Received
    October 4, 2013
    Date of Event
    March 1, 2013
    Report Date
    September 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 377760, LOT# V011515, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 377760, LOT# V011827, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS INTERMITTENT STIMULATION. THE PATIENT NEEDED TO CHARGE VERY FREQUENTLY. THE PATIENT USED TO CHARGE EVERY 2.5 WEEKS AND NOW IT IS EVERY 3 DAYS AND ¿NOT USING IT.¿ IMPEDANCES WERE ALL NORMAL. THE EVENT STARTED 6 MONTHS AGO, BUT WAS ¿MUCH WORSE¿ IN THE PAST 3 WEEKS. THE PATIENT HAD A FEW FALLS, BUT THERE WAS NO CHANGE IN STIMULATION REPORTED CONCURRENT WITH THE FALLS. THE PATIENT COULD BE PERFECTLY STILL AND THE THERAPY WOULD JUST STOP. UPON INTERROGATION IT WAS SHOWN THE DEVICE HAD BEEN USED FOR LESS THAN ONE HOUR IN THE PAST 3 MONTHS. THE PATIENT HAD RECHARGED 15 TIMES IN THE PAST 3 MONTHS FOR ABOUT 1.5 HOURS PER SESSION. THE PLAN WAS TO HAVE THE PATIENT KEEP A DIARY AND MEET WITH THE REPORTER IN ONE WEEK. IT WAS ALSO REPORTED THE PATIENT WAS ON ¿N¿LINK¿ AND WAS NEAR REPLACEMENT, BUT IT WAS UNCLEAR WHAT WAS MEANT BY THIS STATEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504550 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR