BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 7785061 · Received August 15, 2018

    Report

    Report Number
    3007566237-2018-02434
    Event Type
    Malfunction
    Date Received
    August 15, 2018
    Date of Event
    August 13, 2018
    Report Date
    August 22, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    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

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURE REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REP REPORTED ISSUE WITH IMPEDANCES AT A STAGE TWO IMPLANT CASE. THE REP STATED THAT WHEN USING THE CLINICIAN TABLET ,ALL IMPEDANCES ON THE RIGHT SIDE WERE OUT OF RANGE. IT WAS STATED THAT THE DOCTOR REMOVED THE EXTENSION FROM THE HEADER OF THE INS, THEY WIPED OFF COMPONENTS, DISCONNECTED COMPONENTS AND RECONNECTED EVERYTHING. AFTER ATTEMPTING THIS THE IMPEDANCES WERE STILL HIGH. IMPEDANCE VALUES FROM THE CLINICIAN TABLET; C11 2315 C10 2383 C9 2739 C8 2505 811 4748 810 4810 89 5039 911 4938 910 4971 1011 4397OHMS THE REP REPORTED THAT WHEN TESTING USING THE CLINICIAN PROGRAMMER AT 0.7V, ALL IMPEDANCES WERE OUT OF RANGE BUT DID NOT HAVE SPECIFIC VALUES. IMPEDANCES RUN USING THE CLINICIAN PROGRAMMER AT 3V WERE: C8 1494 C9 1581 C10 1494 C11 1482 89 3117 810 3117 811 3142 910 3076 911 3184 1011 2846OHMS IT WAS REVIEWED FOR THE REP HOW IMPEDANCES VALUES CAN BE ELEVATED AT IMPLANT OR WHEN THE AMPLITUDE USED FOR TESTING IS LOWER AND HOW THE TABLET TESTS IMPEDANCES. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED/ ANTICIPATED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) INDICATING THAT THE NEW CLINICIAN TABLET PROGRAMMER DOES NOT TEST AT 3V, UNLESS THE IMPEDANCES ARE 10,000 AND ABOVE. REP NOTED THAT NOTHING WAS OUT OF RANGE AT 3V USING THE CLINICIAN PROGRAMMER TO TEST. THE IMPEDANCES WERE ONLY OUT OF RANGE WITH THE TABLET. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED/ ANTICIPATED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628101 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601

    Patients

    Seq Age Sex Outcome Treatment
    1