BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 10655964 · Received October 9, 2020

    Report

    Report Number
    3004209178-2020-17621
    Event Type
    Malfunction
    Date Received
    October 9, 2020
    Date of Event
    February 14, 2020
    Report Date
    October 9, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169864238
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    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 THAT SINCE REPLACEMENT, THE PATIENT HAS BEEN HAVING MOBILITY SYMPTOMS. THE PATIENT IS IN OFFICE TODAY FOR REPROGRAMMING. THE PATIENT IS PROGRAMMED: LEFT GPI SIDE: 2+3- 5.6MA/90PW/120HZ. THERAPY IMPEDANCE, RIGHT GPI SIDE: 10+11- 6MV/90PW/120HZ. THERAPY IMPEDANCE 649 OHMS/4.6V THE PHYSICIAN IS SEEING "SETTING NOT AVAILABLE" ON THE LEFT SIDE. THE RIGHT GPI IS NORMAL IMPEDANCE. THE PATIENT ALSO SAW OUT OF REGULATION (OOR) MESSAGE AT HOME INTERMITTENTLY SINCE THE REPLACEMENT. THE PATIENT HAD INCREASED TO 5.6 MA AT HOME WHEN THE MESSAGE APPEARS. THEY WOULD DECREASE DOWN TO 5.4 MA AND THE OOR MESSAGE DISAPPEARS. THE PATIENT GRADUALLY INCREASED BACK UP TO 5.7 MA AND THE MESSAGE DID NOT RE-APPEAR. THEY HAVE REPROGRAMMED TO VOLTAGE AND CURRENT, AND SEEN OOR MESSAGE AT 5.7V, BUT THERAPY IMPEDANCE IS SHOWING. THE IMPLANTABLE NEUROSTIMULATOR (INS) IS CHARGED AT 50%. UPON INTERROGATION, THEY SAW THE MESSAGE: SIMULATION OUT OF RANGE, DECREASE AMPLITUDE, CHANGED AMP TO VOLTAGE. THE LEFT SIDE ELECTRODE IMPEDANCE WAS: C0:1023 OHMS C1:896 OHMS C2:935 OHMS C3:915 OHMS 01:1592 OHMS 02:1656 OHMS 03:1850 OHMS 12:1332 OHMS 13:1656 OHMS 23:1248 OHMS THE INS IS IMPLANTED ON THE LEFT CHEST. THEY RE-TESTED IMPEDANCE WITH LEFT ARM EXTENDED: C0:1019 OHMS C1:894 OHMS C2:934 OHMS C3:908 OHMS 01:1595 OHMS 02:1661 OHMS 03:1845 OHMS 12:1332 OHMS 13:1653 OHMS 23:1246 OHMS. THEY HAVE REPROGRAMMED TO A DIFFERENT CONTACT WITH 1V AND THE PATIENT WAS NOT GETTING THERAPY EFFECT. THE PATIENT ALMOST HAD A FALL BUT CAUGHT THEMSELVES. IMPEDANCES/CONTACTS WERE REVIEWED AND THE PHYSICIAN IS DOING THE REPROGRAMMING. THE PATIENT IS ABLE TO TOLERATE USING: LEFT SIDE: C+2- 1MA THERAPY IMPEDANCE 873 OHMS/0.9V. THE PATIENT NEEDED MORE MA C+2- AT 3.5MA WITH NO OOR MESSAGE SEEN AND THERAPY IMPEDANCE 863 OHMS /3.2V.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1123392 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612 00643169864238

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR