BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2032469 · Received March 25, 2011

    Report

    Report Number
    3004209178-2011-02314
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    September 1, 2010
    Report Date
    March 10, 2010
    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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT'S DEVICE WAS REMOVED DUE TO INFECTION "ABOUT SIX MONTHS" PRIOR TO REPORT. IT WAS STATED, THE PT'S HEALTH CARE PROVIDER WAS WAITING FOR INFECTION TO CLEAR BEFORE IMPLANTING NEW DEVICE. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    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 54 YR Required Intervention EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL LEADMVD, LOT# *UK6068972| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL EXTENSION MVD, LOT# *UK6068975| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 7436, LOT# NFU012538P| LEAD: MODEL LEADMVD, LOT# *UK6068974| EXTENSION: MODEL EXTENSION MVD, LOT# *UK6068973| EXPLANTED: