BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 5172565 · Received October 24, 2015

    Report

    Report Number
    3004209178-2015-21328
    Event Type
    Malfunction
    Date Received
    October 24, 2015
    Report Date
    September 30, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3387-40, LOT# V003964, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 3387-40, LOT# V003964, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE PATIENT THAT REPORTED THE IMPLANTABLE NEUROSTIMULATOR (INS) DIDN'T LAST AS LONG AS THEY WERE TOLD THEY WOULD. THE PATIENT WAS IMPLANTED FOR PARKINSON'S DUAL. FURTHER FOLLOW-UP IS BEING CONDUCTED TO DETERMINE WHAT SYMPTOMS, IF ANY, DID THE PATIENT EXPERIENCE, WHAT TROUBLESHOOTING OCCURRED, AND IF THE CAUSE OF THE LONGEVITY ISSUE WAS DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705589 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR