BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 6606068 · Received June 1, 2017

    Report

    Report Number
    3004209178-2017-11481
    Event Type
    Injury
    Date Received
    June 1, 2017
    Report Date
    June 19, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    UDI-DI
    00613994934604
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    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.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR PAR KINSON'S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT A LOW IMPEDANCE OF 64 OHMS ON CONTACT 0-1 PRIOR TO A PROCEDURE. DURING THE PROCEDURE, THE DEVICE WAS REMOVED TWICE, CLEANED, DRIED, AND THE HEADER WAS SUCTIONED. AFTER THE PROCEDURE, THERE WERE LOW IMPEDANCES ON CONTACTS: 0-2, 0-3, 1-2, 1-3, AND 2-3. THERE WERE ALSO HIGH, OUT-OF-RANGE IMPEDANCES ON C-8, C-9, C-10, C-11 AND 8-9. CONTACT 8-9 WAS REPORTEDLY BEING USED FOR THERAPY. THE PATIENT HAD REPORTEDLY FALLEN A FEW TIMES RECENTLY. IT WAS NOTED THEY WOULD CHECK BACK WITH PATIENT AFTER A FEW DAYS TO SEE IF THE IMPEDANCES HAD SETTLED OUT. IT WAS INDICATED THAT THEY MIGHT BE ABLE TO PROGRAM AROUND THE ISSUE. THE PATIENT WAS PROGRAMMED AT 1.7 V, 140 PW, AND 185 HZ ON THE RIGHT AND 2.5 V, 150 PW, AND 185 HZ ON THE LEFT. POST-OPERATIVE IMPEDANCES (OHMS) 0-2: 102 0-3: 50 1-2: 58 1-3: 84 2-3: 103 C-8: 2049/2303 C-9: 3675/4189 C-10: 2752/3543 C-11: 897/3029 8-9: 2907/2988.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM REP. THE REP STATED THEY DID NOT KNOW THE PATIENT'S WEIGHT. ADDITIONAL IMPEDANCE TESTS WERE DONE POST OPERATION WITH NO CHANGES IN RANGES. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. PRE-OPERATIVE IMPEDANCES @ 3.0V TESTING "OUT OF RANGE" (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387984 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601 00613994934604

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention