BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA RC

    MDR report key: 1926417 · Received November 11, 2010

    Report

    Report Number
    3004209178-2010-09359
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 26, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT WAS NOT ABLE TO ADJUST STIMULATION AND A POWER ON RESET (POR) CONDITION OCCURRED. THE DEVICE WAS POWERED OFF. THE PATIENT STATED POR CLEARED, BUT WHEN PATIENT TRIED TO TURN STIMULATION ON THE POR RETURNED. THE PATIENT WAS OUT OF TOWN AND DID NOT HAVE HIS RECHARGER. TROUBLESHOOTING WAS LIMITED DUE TO LACK OF ACCESS TO PRODUCT AND/OR PATIENT. THE PATIENT WAS OR WILL BE TRAVELING AND SEEKING NEW HCP. IT WAS FURTHER REPORTED HCP INDICATED DISPLAY SHOWED "CALL YOUR DOCTOR" ICON. THE HCP FIRST INDICATED A 0X400 (PARITY POR) ON 8840 AND THEN LATER INDICATED A 0X0 ON 8840. THE HCP SYNCED IMPLANTABLE NEURO STIMULATOR (INS) WITH PATIENT PROGRAMMER AND CLEARED INFORMATIONAL POR. THE PATIENT PROGRAMMER (PP) WAS PROMPTED TO CHANGE TIME. AFTER TIME CHANGED, THE HCP WAS ABLE TO TURN PATIENT'S THERAPY BACK ON AND OPERATED 8840 AS USUAL. THE HCP WAS UNABLE TO GET SPECIFICS AS TO A REASON WHY INS HAD A POR CONDITION. IT WAS NOTED PATIENT WAS TO VISIT HCP THIS AFTERNOON. AT THE TIME OF THIS REPORT, NO FURTHER DETAILS WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND WILL BE PROVIDED WHEN IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA RC MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 37612 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37642, LOT# NJZ100847N| IMPLANTED:| EXTENSION: MODEL 37085, LOT# NKN000825V| EXTENSION: MODEL 37085, LOT# NKN000688V| LEAD: MODEL 3387S, LOT# V280394| IMPLANTED:| LEAD: MODEL 3387S, LOT# V280394