BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2230440 · Received August 15, 2011

    Report

    Report Number
    3007566237-2011-06376
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ARRIVED AT THE HOSPITAL WITH A DECUBITUS OF THE DEVICE. THE DEVICE WAS EXPLANTED AND THE EXTENSIONS WERE CUT AT THE LEVEL OF THE NECK. THE DEVICE WAS NOT REPLACED. THE PHYSICIAN PREFERRED TO TREAT THE PATIENT WITH ANTIBIOTICS. THE PATIENT INCURRED NO INJURY AND WAS OKAY.

    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