BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 5522657 · Received March 24, 2016

    Report

    Report Number
    3004209178-2016-05263
    Event Type
    Malfunction
    Date Received
    March 24, 2016
    Date of Event
    February 26, 2016
    Report Date
    March 24, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL FOR A CLINICAL STUDY VIA A MANUFACTURING REPRESENTATIVE REPORTED IMPEDANCE READINGS WERE ABNORMAL FOR THE PATIENT AND MAY INDICATE A SHORT IN THE SYSTEM. A GENERAL THERAPEUTIC IMPEDANCE CHECK WAS DONE AT 0.7 VOLTS WITH THE FOLLOWING RESULTS: 8/C-1337, 9/C-1341, 10/C-2362, 11/C-2125, 8/9-32, 8/10-3226, 8/11-3063, 9/10-3240, 9/11-3063 AND 10/11-4053. IT APPEARED LEAD CONTACT 8/9 MAY HAVE A SHORT CIRCUIT WHICH WAS MAYBE ASSOCIATED WITH THE PATIENT BEING STIMULATED OFF NONE OF THE CONTACTS. REPROGRAMMING WAS NOT NEEDED. THEY WERE GOING TO CONTINUE TO WATCH IMPEDANCE. THERE HAD BEEN NO SYMPTOMS RELATED TO THE PROBLEM, NO STIMULATION ON 8/9 COMBINATION. TROUBLESHOOTING INCLUDED IMPEDANCE CHECK AT THE NEXT VISIT WITH THE SAME VALUE, 8/9-32 OHMS. THE CAUSE WAS NOT DETERMINED, SPECULATION IS A SHORT CIRCUIT BETWEEN THE CONTACTS IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180295 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601

    Patients

    Seq Age Sex Outcome Treatment
    1