BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1854114 · Received September 30, 2010

    Report

    Report Number
    3004209178-2010-07496
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Date of Event
    January 1, 2010
    Report Date
    September 3, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). ANALYSIS OF THE PT PROGRAMMER (MODEL#: 37742, SN#: (B)(4)) REVEALED THAT THE DEVICE BATTERIES HAD LEAKED WITHIN THE BATTERY COMPARTMENT. THE BOTTOM CASE ASSEMBLY WAS REPLACED DUE TO BEING DAMAGED / OUT OF MANUFACTURER SPECIFICATION. IT WAS NOTED THAT THE ANTENNA JACK WAS RE-SOLDERED AS A PREVENTATIVE MEASURE.

    Description of Event or Problem · 1

    A PT WAS UNABLE TO ADJUST STIMULATION, AS THE DEVICE UNDERWENT A POWER ON RESET (POR) CONDITION. A "CALL YOUR DOCTOR" ICON WAS INDICATED. IT WAS NOTED THAT THE PT'S PROGRAMMER WAS REPLACED A FEW MONTHS AGO AS THE PT WAS EXPERIENCING PROBLEMS WITH IT. IT WAS AT THAT TIME THAT THE PT WASN'T ABLE TO TURN STIMULATION ON, AND WAS GETTING A POR MESSAGE ON THEIR PROGRAMMER. THE PT NOTED HE HAD NOT HAD STIMULATION FOR SEVERAL MONTHS / SINCE EARLY SUMMER. IT WAS NOTED THAT THE PHYSICIAN PROGRAMMER WAS INDICATING A POR CONDITION AS WELL, BUT NOT WITH A TYPICAL CODE. THIS POR WAS NOTED TO HAVE OCCURRED SEVERAL TIMES ON (B)(6) 2010, AND TWICE MORE UPON CONSULTATION WITH A COMPANY REP. THE PHYSICIAN PROGRAMMER INDICATED "SESSION WILL RESTART", AND WHEN "OK" WAS SELECTED THE DEVICE CONTINUALLY LOOPED BACK TO THE THERAPY DESKTOP. IT WAS NOTED THAT NEUROSTIMULATOR DEVICE BATTERY DEPLETION WAS SUSPECTED, HOWEVER, IT WAS FURTHER NOTED THAT IT WAS NOT KNOWN WHY THE ISSUE WAS MANIFESTING ITSELF IN THIS WAY. THE DEVICE WAS PLANNED TO BE EXPLANTED SOMETIME IN THE NEAR FUTURE. THE PT'S OUTCOME WAS NOT REPORTED. ADDITIONAL INFO IS BEING REQUESTED, AND WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB007434N| IMPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD043267N| LEAD: MODEL 3890, LOT# V027802| IMPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD019522N| LEAD: MODEL 3776, LOT# V015021| EXPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3890, LOT# V001889| EXPLANTED:| IMPLANTED: