BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2161798 · Received July 8, 2011

    Report

    Report Number
    3004209178-2011-05219
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    February 18, 2011
    Report Date
    June 27, 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
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A TINGLING SENSATION IN THE POCKET WHICH WAS FOUND TO BE RELATED TO THE RIGHT EXTENSION COMPONENT. THE EXTENSION WAS REPLACED. THE PT RECOVERED WITHOUT SEQUELAE.

    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 EXPLANTED:| EXTENSION: MODEL EXTENSION MVD, LOT# NHU226610| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL EXTENSION MVD, LOT# NHU226611| EXPLANTED: