BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 4892529 · Received July 6, 2015

    Report

    Report Number
    3004209178-2015-12815
    Event Type
    Injury
    Date Received
    July 6, 2015
    Report Date
    June 15, 2015
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40, LOT# V042554, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD; PRODUCT ID 3387S-40, LOT# V042554, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED SHOCKING AS WELL AS A RETURN OF TREMORS WHICH HAD OCCURRED IN 2010. THE ENTIRE IMPLANTED SYSTEM WAS REPLACED ON (B)(6) 2010. IMPLANT WAS FOR NERVOUS TREMOR. FURTHER FOLLOW-UP IS BEING CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435522 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Required Intervention