BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2211100 · Received August 8, 2011

    Report

    Report Number
    3004209178-2011-06153
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 13, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A POWER-ON-RESET (POR) CONDITION WAS REPORTED, AS WELL AS THE "CALL YOUR DOCTOR" ICON, AND AN "OUT OF REGULATION (OOR) MESSAGE. THE UPPER LIMIT WAS DISPLAYED ON THE OOR. THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION. THE NEUROSTIMULATOR WAS FULLY CHARGED AND THE PROGRAMMER BATTERIES WERE CHARGED AS WELL. THE OOR MESSAGE APPEARED WHEN THE PATIENT ATTEMPTED TO INCREASE AMPLITUDE. THE REPORTED EVENTS FIRST OCCURRED ABOUT 1.5 WEEKS PRIOR TO REPORT. THE PATIENT RECHARGED THE NEUROSTIMULATOR EVERY 20 DAYS. THE OOR MESSAGE COULD NOT BE REPLICATED IN THE CLINIC BY A MANUFACTURER REPRESENTATIVE ON (B)(6) 2011. ON THE SAME DATE, OUT OF RANGE IMPEDANCES WERE ALSO NOTED. IMPEDANCES ON 1-5 WERE >40,000 OHMS AND ON 2-3 WERE <150 OHMS. ALL OTHER VALUES WITH REFERENCE 2 WERE NOT OUT OF RANGE AND ABOVE 506. ALL VALUES WITH REFERENCE 5 WERE IN THE RANGE OF 26,242-32,949 OHMS. ELECTRODE 5 HAD PREVIOUSLY BEEN REMOVED FROM THE PROGRAMMING DUE TO HIGH IMPEDANCES. AT 3.0V SOME ELECTRODES SHOWED <10,000 OHMS. THE PATIENT FELT STIMULATION IN THE WRONG LOCATION (STOMACH) BEGINNING ONE WEEK PRIOR TO REPORT. THE PATIENT THOUGH SHE MAY HAVE TRIPPED BEFORE THE SYMPTOMS BEGAN OCCURRING (ALTHOUGH THE PATIENT DID NOT RECALL WHEN SHE HAD TRIPPED). THE PATIENT DID NOT GET THE OOR MESSAGE 100% OF THE TIME, BUT WHEN SHE DID IT WOULD RESTRICT HER FROM INCREASING STIMULATION IN THE MIDDLE OF THE DAY. THE PATIENT WAS TO CONTINUE MONITORING THE ISSUE AND TO FOLLOW-UP IF IT PERSISTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR LEAD: MODEL 3777, LOT# V065562024| PROGRAMMER: MODEL 37743, LOT# NKE105646N| EXPLANTED:| LEAD: MODEL 3777, LOT# V093192035| IMPLANTED:| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA037843N