BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4850634 · Received June 17, 2015

    Report

    Report Number
    3004209178-2015-11772
    Event Type
    Injury
    Date Received
    June 17, 2015
    Date of Event
    May 26, 2015
    Report Date
    May 26, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37086, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. PRODUCT ID: 37086, SERIAL# (B)(4), IMPLANTED: 2015-(B)(6), PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# VA0UWVA, IMPLANTED: 2015-(B)(6), PRODUCT TYPE: LEAD. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3387S-40, LOT# VA0UWST, IMPLANTED: 2015-(B)(6), PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE HEALTHCARE PROFESSIONAL (HCP) HAD PROBLEMS WITH OPEN CIRCUITS ON CONTACT ZERO OF THE EXTENSION. IMPEDANCES WERE MEASURED TO BE GREATER THAN 40,000 OHMS ON CONTACT ZERO. WHEN THE EXTENSION WAS INITIALLY CONNECTED TO THE IMPLANTABLE NEUROSTIMULATOR (INS), IMPEDANCES WERE MEASURED TO BE FINE. THE HCP HAD WIPED OFF ALL CONNECTIONS. THE INS WAS THEN PLACED IN THE POCKET AND THE POCKET WAS CLOSED. BEFORE ENDING THE PROCEDURE, IMPEDANCES WERE MEASURED AGAIN AND AN OPEN WAS FOUND ON CONTACT ZERO. THE HCP OPENED THE POCKET AND TOOK THE INS OUT. IMPEDANCES WERE MEASURED TO BE NORMAL WITH THE INS SITTING IN THE POCKET. THE HCP STATED THIS USUALLY INDICATED THERE WAS A POSITIONAL BREAK AND IT SHOWED UP WHEN THE WIRES WERE TUCKED IN THE POCKET. THE HCP BELIEVED THE EXTENSION BREAK WAS IN ABOUT A 3-4 INCH LENGTH THAT WAS LIKE A TRANSITION PIECE BETWEEN THE CORD WIRE AND THE STICK WIRE. THE SEGMENT WHERE IT INSERTS INTO THE INS WAS VULNERABLE DUE TO NORMAL MANIPULATION. THE HCP REPLACED THE EXTENSION WHICH ADDED ABOUT 25 MINUTES TO THE SURGERY. THE REPLACEMENT EXTENSION WORKED FINE. THERE WAS NO PATIENT INJURY OR DEATH AND THEY HAD RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394029 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention