BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2565843 · Received May 9, 2012

    Report

    Report Number
    3007566237-2012-01013
    Event Type
    Malfunction
    Date Received
    May 9, 2012
    Date of Event
    April 11, 2012
    Report Date
    October 5, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3389S-40, LOT# V867003, IMPLANTED: 2012-(B)(6), PRODUCT TYP LEAD PRODUCT ID 3389S-40, LOT# V878959, IMPLANTED: 2012-(B)(6), PRODUCT TYP LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN IMPEDANCE ISSUE WITH A LOW OUT OF RANGE IMPEDANCE VALUE. THE PATIENT WAS HAVING THEIR INITIAL PROGRAMMING SESSION AND 0-3 PAIR WAS 99 OHMS. OTHER IMPED: C0=468, C1=1308, C2=1149, C3=468, 01=1364, 02=1168, 12=1684, 13=1318, 23=1112. THEY HAD NOT DONE ANY THRESHOLD TESTING YET SO THEY PLANNED TO DO THAT AND SEE WHAT PROGRAMMING SEEMED TO BE EFFECTIVE FOR THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR