BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2842535 · Received November 21, 2012

    Report

    Report Number
    3007566237-2012-02809
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Report Date
    October 25, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 748251, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: EXTENSION; PRODUCT ID: 748251, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: EXTENSION; PRODUCT ID: 7426, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID: 3389-40, LOT#: J0228211V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE: LEAD; PRODUCT ID: 3389-40, LOT#: J0228211V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN FALLING. IT WAS ALSO REPORTED THAT THE IMPEDANCE ON CONTACT 2 OF THE RIGHT SIDE DEVICE WAS "APPROXIMATELY 16,000" OHMS. THE PATIENT WAS PROGRAMMED WITH THIS CONTACT, BUT HE WAS GETTING "GREAT BENEFIT". THE ABNORMAL IMPEDANCE WAS NOTICED THE DAY OF THE REPORT, BUT IT WAS POSSIBLE THAT THE IMPEDANCE PROBLEM PRE-DATED THAT SESSION. THE HEALTH CARE PROVIDER (HCP) WAS NOT "OVERLY CONCERNED" REGARDING THE HIGH IMPEDANCE BECAUSE THE PATIENT WAS GETTING "GOOD BENEFIT". IT WAS ALSO REPORTED THAT THE IMPEDANCE ON CONTACT 3 OF THE LEFT SIDE DEVICE WAS "AROUND 7500" OHMS, BUT THIS CONTACT WAS NOT USED IN PROGRAMMING SO THERE WAS NO CONCERN. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2012 REPORTED THAT THE PATIENT WAS DOING "WELL" AND THERE HAD BEEN NO FURTHER ISSUES. THE HCP HAD NO PLANS TO FOLLOW-UP WITH THE PATIENT AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37602

    Patients

    Seq Age Sex Outcome Treatment
    1