BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2223874 · Received August 18, 2011

    Report

    Report Number
    3004209178-2011-06547
    Event Type
    Injury
    Date Received
    August 18, 2011
    Report Date
    August 9, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STIMULATOR HAS BEEN RETURNED TO THE MFR FOR ANALYSIS. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED IMPEDANCES INDICATED THERE WERE SHORTS ON ELECTRODE 1, 2, AND 3. THE BATTERY WAS REPLACED DUE TO NORMAL BATTERY DEPLETION. THERE WAS NO PT INJURY, AND THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| LOT# NFD115222H| IMPLANTABLE NEURO STIMULATOR: MODEL 7428,| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU198733V| LEAD: MODEL 3391S-40, LOT# V159369| LEAD: MODEL 3391S-40, LOT# V159369| IMPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU198734V