BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2191103 · Received July 29, 2011

    Report

    Report Number
    9614453-2011-05876
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 4, 2011
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NEUROSTIMULATOR HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PREVIOUSLY USED DEVICE SETTINGS NO LONGER PROVIDED THE SAME RESULT. ANY ADJUSTMENTS TO THE DEVICE SETTINGS THAT WERE ATTEMPTED PROVIDED NO IMPROVEMENT IN THE PT'S SYMPTOMS. THE PT'S IMPLANTABLE NEUROSTIMULATOR WAS, THEN, EXPLANTED AND REPLACED. THERE WAS NO INJURY TO THE PT. AFTER IMPLANTATION WITH THE NEW DEVICE, THERAPEUTIC BENEFIT WAS RESTORED USING THE PREVIOUS DEVICE'S SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MEDTRONIC EUROPE SARL 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention EXPLANTED:| LEAD: MODEL UNK, LOT# UNK| LEAD: MODEL UNK, LOT# UNK| IMPLANTED:| EXPLANTED:| IMPLANTED: