BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2100351 · Received May 13, 2011

    Report

    Report Number
    3004209178-2011-03510
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Date of Event
    July 1, 2010
    Report Date
    April 27, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED IN (B)(6) 2010 THAT THERE WAS AN ISSUE ABOUT A RECHARGER. AN OVER-DISCHARGE WAS SUSPECTED, THE PATIENT LOST STIMULATION (B)(6) PRIOR. IT WAS LATER NOTED THAT THE PATIENT WAS OVER-DISCHARGED. IN REPORTING FROM (B)(6) 2011, THERE WAS A POWER ON RESET CONDITION FOLLOWING A PHYSICIAN MODE RECHARGE. ADDITIONAL INFORMATION RECEIVED NOTED THAT THE POWER ON RESET CLEARED BUT THE DEVICE WAS NOW UNABLE TO HOLD A FULL CHARGE LONGER THAN A FEW HOURS. THE MANUFACTURER'S REPRESENTATIVE WAS AWARE OF ONE RESTART OF THE DEVICE BUT THE PATIENT BELIEVED THAT HE PERFORMED SEVERAL ('AT LEAST 20') AT HOME. THE PATIENT WAS NOW ON THE SCHEDULE FOR A BATTERY REPLACEMENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 7434A, LOT# NGL008013P| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7495LZ, LOT# NHK017008V| PROGRAMMER: MODEL 37743, LOT# NKE130357N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT# J0220133V| IMPLANTED:| IMPLANTED:| LOT# NAT142630H| IMPLANTABLE NEURO STIMULATOR: MODEL 7425,| LEAD: MODEL 39565-65, LOT# N210707002| ACCESSORY: MODEL 37752, LOT# NKA128778N