BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 3037965 · Received April 5, 2013

    Report

    Report Number
    3004209178-2013-04713
    Event Type
    Injury
    Date Received
    April 5, 2013
    Report Date
    March 22, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40, LOT# V230077, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3387S-40, LOT# V230077, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2010. PRODUCT TYPE: EXTENSION: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2010. PRODUCT TYPE: EXTENSION: PRODUCT ID 7436, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S FIRST IMPLANT / DBS DEVICE HAD TO BE REPLACED BECAUSE HE HAD A BROKEN LEAD. THE MANUFACTURER'S DEVICE REGISTRY SHOWED THAT WHEN THE PATIENT'S FIRST NEUROSTIMULATOR WAS REPLACED, BOTH EXTENSIONS WERE REPLACED AS WELL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140708 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention