BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2379385 · Received December 16, 2011

    Report

    Report Number
    3004209178-2011-09868
    Event Type
    Injury
    Date Received
    December 16, 2011
    Report Date
    November 29, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3389S-40 LOT# V053074 IMPLANTED: (B)(6) 2007 EXPLANTED: NA, LEAD MODEL 3389S-40 LOT# V053074 IMPLANTED: (B)(6) 2007 EXPLANTED: NA, EXTENSION MODEL 7482A51 SERIAL# (B)(4) IMPLANTED: (B)(6) 2007 EXPLANTED: NA, EXTENSION MODEL 7482A51 SERIAL# (B)(4) IMPLANTED: (B)(6) 2007 EXPLANTED: NA, PROGRAMMER MODEL 7436 SERIAL# (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE EXTENSION HAD "WORKED LOOSE" AT THE SET SCREW. IT WAS NOTED THAT IT WAS POSSIBLE THAT IT CAME LOOSE BECAUSE IT MAY NOT HAVE BEEN TIGHTENED APPROPRIATELY. THE DEVICE WAS RETIGHTENED AND THE PATIENT WAS DOING FINE. ADDITIONAL REVIEW FOUND THIS EVENT HAD ALSO BEEN REPORTED IN MANUFACTURER REPORT # 3007566237-2011-09262. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THE EVENT WILL BE REPORTED UNDER THIS MANUFACTURER REPORT NUMBER (3004209178-2011-09868).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S KINETRA WAS REPLACED THE PREVIOUS MONTH. EVERYTHING WAS FINE. THE PATIENT THEN EXPERIENCED INTERMITTENT LOSS OF THERAPY, AND INTERMITTENT IMPEDANCES ABOVE 4,000 OHMS ON THE LEFT. A REVISION WAS PLANNED FOR (B)(6) 2011. IT WAS NOTED THAT PRIOR TO THE DEVICE CHANGEOUT THERE WERE NO INTEGRITY ISSUES, AND ONLY THE POCKET WAS WORKED ON DURING THE CHANGEOUT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS A LOOSE CONNECTION AT CONTACT #2. THE CASE WAS RESOLVED. 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
    1 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT PUERTO RICO OPERATIONS CO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention