BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 7809546 · Received August 23, 2018

    Report

    Report Number
    3004209178-2018-18998
    Event Type
    Malfunction
    Date Received
    August 23, 2018
    Date of Event
    August 17, 2018
    Report Date
    September 21, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00613994761071
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT ID (B)(4) LOT# SERIAL# (B)(4) IMPLANTED: (B)(4) 2015 EXPLANTED: (B)(4) 2018 PRODUCT TYPE EXTENSION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING THEIR IMPLANTABLE NEUROSTIMULATOR (INS) FOR DYSTONIA AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE INS WAS AT END OF LIFE (EOL) DUE TO NORMAL BATTERY DEPLETION. IT WAS REPORTED THAT ON FRIDAY THE CONTACT 0 WAS NOTED AS HIGH BUT NOT IN USE FOR PROGRAMMING. PRIOR TO THE REPLACEMENT, THE IMPEDANCES WERE AS FOLLOWS: C1 WAS 1668 OHMS WHICH WAS PROGRAMMED, 12 1588 OHMS, AND 13 WAS 1962 OHMS. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM MANUFACTURING REPRESENTATIVE INDICATING THAT THE CAUSE OF THE HIGH IMPEDANCE ISSUE WAS DUE TO THE EXTENSION. THIS WAS CONFIRMED BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649566 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37603 00613994761071

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR