BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2887467 · Received December 27, 2012

    Report

    Report Number
    3004209178-2012-12297
    Event Type
    Injury
    Date Received
    December 27, 2012
    Report Date
    August 2, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, NEU_WRENCH_ACC, PRODUCT TYPE ACCESSORY PRODUCT ID, 37085-60 LOT# SERIAL# (B)(4). IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3387S-40 LOT# V951526, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A "MINOR" SHOCKING OR JOLTING SENSATION OCCASIONALLY AT THE POCKET SITE AND ON THE RIGHT SIDE IT THE IMPLANT. WHEN THE DEVICE WAS PHYSICALLY MANIPULATED OR GENTLY COUGHED, HIGH IMPEDANCES WERE REPORTED. THE PROGRAMMING NURSE NOTICED THAT THE IMPEDANCES WERE UNUSUALLY HIGH INTERMITTENTLY. IT WAS NOTED THAT THE TORQUE WRENCH DID NOT WORK PROPERLY DURING THE IMPLANT SURGERY. THE PHYSICIAN SUSPECTED THAT THERE WAS A WEAK CONNECTION BETWEEN EXTENSION AND THE IMPLANTABLE NEUROSTIMULATOR (INS) BECAUSE THE "FAULTY" TORQUE WRENCH DID NOT PRODUCE THE APPROPRIATE FORCE TO LOCK THE LEAD IN. IT WAS NOTED THAT HUMAN ERROR WAS NOT RULED OUT AS A FACTOR. THE PATIENT HAD A REVISION SURGERY. THE POCKET WAS OPENED, THE INS WAS PULLED OUT, THE LEAD WAS DISCONNECTED AND WIPED, AND THE HARDWARE WAS RECONNECTED. IMPEDANCES WERE TAKEN TWICE INTRA-OPERATIVELY AND THE VALUES "WENT DOWN SIGNIFICANTLY" AFTER THE RECONNECTION COMPARED TO THE STARTING BASELINE PRE-OPERATIVELY. THE PATIENT'S STATUS WAS REPORTED AS ALIVE WITH NO INJURY AND NO ADVERSE EVENT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS FREE OF THE SHOCKING SENSATION AND FELT FINE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention