BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 1150427 · Received September 5, 2008

    Report

    Report Number
    3004209178-2008-05516
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 6, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: BURRHOLE CAP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SINCE IMPLANT, IMPEDANCE READINGS HAVE BEEN >4000 OHMS. IT WAS ALSO NOTED THAT THE CAP SITE WAS ACCESSED PREVIOUSLY. THERE IS SOME "OOZING" NOTED FROM THE CAP SITE NOW. THE PATIENT WAS RECEIVING THERAPEUTIC EFFECTS FROM THE DEVICE. NO OUTCOME WAS REPORTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD MODEL 3387S| EXPLANTED:| LEAD MODEL 3387S LOT# V109650| IMPLANTED:| EXTENSION MODEL 7482A LOT# NHU178293V| IMPLANTED:| IMPLANTED:| STIM ACCESSORY MODEL BURRHOLE CAP LOT# UNKNOWN| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION MODEL 7482A LOT#NHU178117V| EXPLANTED: