BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4261266 · Received November 19, 2014

    Report

    Report Number
    3004209178-2014-21841
    Event Type
    Malfunction
    Date Received
    November 19, 2014
    Date of Event
    October 31, 2014
    Report Date
    October 31, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 7 482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION; PRODUCT ID 3387S-40, LOT# V265356, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 3387S-40, LOT# V230077, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PROBLEM WITH THE PATIENT PROGRAMMER AND THE PATIENT WAS NOT ABLE TO MAKE ADJUSTMENTS WITH OR WITHOUT THE ANTENNA ATTACHED. THE HEALTHCARE PROFESSIONAL STATED THE PATIENT¿S ¿SYSTEM WAS NOT WORKING¿ AND WHEN THEY TRIED TO USE THE PATIENT PROGRAMMER THEY GOT A POOR COMMUNICATION SCREEN. A DAY PRIOR TO THIS REPORT THE PATIENT WAS ABLE TO SYNC NORMALLY. THE MORNING OF THIS REPORT THE PATIENT¿S STIMULATION WAS NOT ON AND THE HCP WAS TRYING TO TURN IT ON, BUT IT WOULD NOT COMMUNICATE. NO ERROR CODES WERE SEEN AND THE PATIENT PROGRAMMER BATTERIES WERE CHANGED THE DAY PRIOR TO THIS REPORT. THE PATIENT WAS HAVING MORE TROUBLE AMBULATING THE DAY OF THIS REPORT AND THERE WAS MORE STUMBLING NOTED. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750725 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR