BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3213311 · Received July 9, 2013

    Report

    Report Number
    3004209178-2013-11490
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    June 13, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    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 PRODUCTS: PRODUCT ID: 3387, LOT# J0546668V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. PRODUCT ID: 3387, LOT# J0527910V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 64001, LOT# N269144, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: ADAPTER. PRODUCT ID: 7482A95, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748266, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 64001, LOT# N259553, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: ADAPTER. PRODUCT ID: 37612, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 7482A95, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748266, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005,EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37612, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED TO HAVE AN EXPLORATORY REVISION OF THE LEAD ON (B)(6) AS THERE WAS A SUSPECTED ISSUE WITH THE LEAD REGARDING IMPEDANCES. IT WAS UNKNOWN IF AN X-RAY HAD BEEN TAKEN. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THEY DETERMINED THAT THE ISSUE WAS WITH THE EXTENSIONS, OR POSSIBLY THE ADAPTORS, ON BOTH SIDES. IMPEDANCES ON THE LEAD WERE ALL FINE. WHEN THE SYSTEM WAS RECONNECTED WITH NEW STRETCH COIL EXTENSIONS IMPEDANCES WERE ALL NORMAL. IT WAS NOTED THAT THE PATIENT HAD BEEN IMPLANTED WHEN HE WAS (B)(6), AND THE BATTERIES WERE IN THE ABDOMEN BUT THEY HAD CHOSEN NOT TO USE THE LONGEST EXTENSIONS POSSIBLE WHEN THEY FIRST DID THE SURGERY. THE PHYSICIAN SUSPECTED THAT THE HIGH IMPEDANCES WERE DUE TO THE GROWTH OF THE PATIENT, AND THE POSSIBLE STRAIN IT PUT ON THE EXTENSION CONNECTIONS. THE PHYSICIAN OPTED TO PUT IN THE LONGEST EXTENSIONS THIS TIME AROUND. IT WAS NOTED THAT THE PATIENT WAS RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313372 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention