BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3686074 · Received March 18, 2014

    Report

    Report Number
    3004209178-2014-04543
    Event Type
    Injury
    Date Received
    March 18, 2014
    Report Date
    March 10, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 64001, LOT# N242249, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ADAPTER. PRODUCT ID: 64001, LOT# N412086, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: ADAPTER. PRODUCT ID: 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID: 64001, LOT# N242249, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ADAPTER. PRODUCT ID: 3389S-40, LOT# V479550, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: EXTENSION. PRODUCT ID: 64001, LOT# N412086, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: ADAPTER. PRODUCT ID: 3387-40, LOT# J0206376V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE: LEAD. PRODUCT ID: 748251, SERIAL# (B)(4),IMPLANTED: (B)(6) 2003, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: 2010-(B)(6), EXPLANTED: 2014-(B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT HAD PRESENTED AGAIN WITH AN INCONSISTENT LOSS OF THERAPY ON THE LEFT SIDE, RIGHT IMPLANTABLE NEUROSTIMULATOR. IT WAS NOTED THAT IMPEDANCES AND PALPATION HAD NOT SHOWN ANYTHING. THE HEALTHCARE PROFESSIONAL WENT INTO THE POCKET AND FOUND A NEW EXTENSION ISSUE. THE DEVICE HAD ONE NEW EXTENSION AND ONE OLD WITH AN ADAPTOR. THE NEW EXTENSION WAS FRACTURED. BOTH EXTENSIONS WERE REPLACED AND THE ADAPTOR WAS REMOVED. ADDITIONAL INFORMATION WAS REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED HAD A READOUT FROM THE DEVICE THAT SHOWED HIGH IMPEDANCES ON COMBINATIONS THAT CONTAINED EITHER ELECTRODE 0 OR 8. THE PATIENT WAS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158182 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00022 YR Required Intervention