BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4100345 · Received September 18, 2014

    Report

    Report Number
    3007566237-2014-02632
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389-28, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3389-28, LOT# 0207168589, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH IMPEDANCES ¿>40000¿ OHMS WERE MEASURED ON CONTACT 11 OF THE PATIENT¿S SYSTEM. THE PATIENT¿S PHYSICIAN WAS REPORTED TO HAVE ¿NOT BELIEVED IT WAS A PROBLEM WITH THE IMPLANT¿ AND INSTEAD ¿SAID IT MUST BE A HARDWARE ISSUE.¿ THE PATIENT UNDERWENT REPROGRAMMING AS A RESULT OF THE EVENT. IT WAS NOTED THE ISSUE HAD BEEN ¿REPROGRAMMED AROUND.¿ IT WAS ¿UNKNOWN¿ WHETHER THE PATIENT HAD EXPERIENCED ANY SYMPTOMS OR COMPLICATIONS DUE TO THE EVENT. THE PATIENT¿S OUTCOME WAS UNAVAILABLE AT THE TIME OF REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE PATIENT WAS "RECEIVING PROPER THERAPY" AT THE TIME OF FOLLOW-UP. THE ISSUE WAS REPORTEDLY DETERMINED TO BE A HIGH IMPEDANCE ISSUE AND "THUS A CONDUCTOR WIRE FRACTURE." FURTHER TROUBLESHOOTING WAS "NOT NECESSARY" AT THE TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580122 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37601

    Patients

    Seq Age Sex Outcome Treatment
    1