BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2834184 · Received November 15, 2012

    Report

    Report Number
    3004209178-2012-10323
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Report Date
    October 17, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    PP70009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: EXTENSION: PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: EXTENSION: PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 3387S-40, LOT# V006354, IMPLANTED: (B)(6) 2007. PRODUCT TYPE: LEAD: PRODUCT ID 3387S-40, LOT# V006354, IMPLANTED: (B)(6) 2007. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD AN APPOINTMENT WITH HER PHYSICIAN AND MANUFACTURER REPRESENTATIVE ON (B)(6) 2012. IT WAS STATED THAT THE PATIENT'S DEVICE WAS REPROGRAMMED. THE PARAMETERS WERE CHECKED AND SHE WAS TOLD THAT "IT WAS UNKNOWN AS TO WHY THIS HAPPENED". IT WAS STATED THAT THE PATIENT INITIALLY RECEIVED THE OUT-OF-REGULATION (OOR) MESSAGE WHEN SHE WAS TRY ING TO TURN THE STIMULATOR OFF AT NIGHT. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS UNABLE TO ADJUST STIMULATION. THE PATIENT RECEIVED THE "CALL YOUR DOCTOR" ICON AND AN OUT OF REGULATION (OOR) CONDITION WAS REPORTED ON HER RIGHT IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT SAW THE OOR MESSAGE THE NIGHT PRIOR TO THIS REPORT WHEN SHE TRIED TO TURN HER STIMULATION OFF. THE PATIENT SYNC'D WITH HER PATIENT PROGRAMMER AND SHE SAW THE OOR MESSAGE WHICH SHE WAS ABLE TO GET PAST. ADDITIONAL INFORMATION RECEIVED 5 DAYS LATER REPORTED A MANUFACTURER REPRESENTATIVE SAW AN OOR MESSAGE ON THE PATIENT PROGRAMMER PRIOR TO INTERROGATING THE PATIENT'S INS BUT SINCE RECEIVING THE OOR MESSAGE THERE WERE NO ISSUES. IT WAS NOTED THE OOR WAS "IDIOPATHIC" AT THE TIME. IMPEDANCES WERE ALL NORMAL. THERAPY IMPEDANCES WERE TESTED WHEN THE PATIENT WAS LOOKING TOWARDS THE REPRESENTATIVE, AWAY FROM, AND WHEN THE PATIENT'S HEAD WAS TILTED TOWARDS AND AWAY FROM THE INS; ALL MEASUREMENTS WERE 1083 OHMS. PALPITATION ELICITED NO CHANGES. THE OOR CONDITION COULD NOT BE RECREATED BY INCREASING STIMULATION PARAMETER. ADDITIONAL INFORMATION RECEIVED 2 WEEKS LATER REPORTED THE PATIENT'S CONCERNS WERE RESOLVED FOLLOWING HER APPOINTMENT WITH HER MANUFACTURER REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT PUERTO RICO OPERATIONS CO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1