BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 4812830 · Received June 2, 2015

    Report

    Report Number
    3004209178-2015-10139
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    July 21, 2007
    Report Date
    May 7, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V021705, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V021705, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SENSATIONS IN EXTENSION TRACT TWINGING. IMPEDANCES WERE TESTED AND WERE IN RANGE. THE OUTCOME WAS ONGOING. NO ACTIONS WERE TAKEN AND NO HOSPITALIZATIONS RELATED TO THE EVENT. THE ETIOLOGY WAS PROGRAMMING/STIMULATION. THERE WAS AN UNDESIRABLE CHANGE IN STIMULATION. THE PATIENT HAD A TWINGING SENSATION FROM IMPLANTABLE NEUROSTIMULATOR (INS) TO EXTENSION/LEAD CONNECTION IF IT TURNED HEADS TO LEFT WHEN THE DEVICE WAS STIMULATING. THE SEVERITY WAS MILD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355207 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00025 YR