BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 1850923 · Received September 29, 2010

    Report

    Report Number
    3007566237-2010-07443
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    August 30, 2010
    Report Date
    September 1, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY USAGE WAS AROUND 60% WHEN THE STIMULATOR STOPPED WORKING FOR NO APPARENT REASON. THE DOCTOR REPORTED THAT THE PT HAD SPENT SOME TIME TO AN "EOLIC WIND TOWER" AND AFTER THAT THE BATTERY DEPLETION OCCURRED. THE IMPLANTABLE NEUROSTIMULATOR WAS IMMEDIATELY REPLACED. THE DOCTOR DISPOSED OFF THE DEVICE SO IT COULD NOT BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PT WAS OK FOLLOWING REPLACEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention