BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 5289181 · Received December 11, 2015

    Report

    Report Number
    3007566237-2015-03766
    Event Type
    Injury
    Date Received
    December 11, 2015
    Date of Event
    November 17, 2015
    Report Date
    August 2, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) VIA A MFR REPRESENTATIVE (REP). IT WAS REPORTED THAT THE LEFT IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY AND EXTENSION WERE REPLACED ON (B)(6).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT PRIOR TO THE SURGERY, AN IMPEDANCE MEASUREMENT WAS PERFORMED AND RESULTED IN ELECTRODE 3 BEING GREATER THAN 40,000 OHMS. THE PATIENT ALSO EXPERIENCED A LOSS OF EFFICACY AS THE IMPEDANCE ISSUE WAS AFFECTING THE PATIENT'S LEFT IMPLANTABLE NEUROSTIMULATOR (INS). DURING THE PROCEDURE, BOTH THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET AND THE LEAD/EXTENSION CONNECTION WERE OPENED. IT WAS STATED AT ELECTRODES 0<(>&<)>1 IMPEDANCES WERE MEASURED AT 27 OHMS BUT THE PATIENT WAS NOT PROGRAMMED ON THESE ELECTRODES. THE REP ALSO REPORTED THAT THE PROCEDURE DID NOT RESULT IN A DEVICE REPLACEMENT AS DISCONNECTING AND RECONNECTING THE SYSTEM RESOLVED THE HIGH IMPEDANCE ISSUES. TESTING IMPEDANCE USING THE MULTI-LEAD TRIAL CABLE CONFIRMED NORMALIZED IMPEDANCES ON ELECTRODE 3.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A HEALTH CARE PROVIDER (HCP) REPORTED THAT NO INTERVENTIONS WERE PLANNED. THE PATIENT'S PARKINSON'S DISEASE HAD ADVANCED AND THEIR HEALTH CARE PROVIDER (HCP) WAS NOT SURE IF THE PATIENT WOULD HAVE A REVISION SURGERY.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819464 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 3387-40 J0306809V

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention