BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 1070193 · Received July 3, 2008

    Report

    Report Number
    3004209178-2008-03766
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 9, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TUNNELING TOOL WAS RETURNED FOR ANALYSIS. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, WHILE THE SURGEON WAS USING THE TUNNELING TOOL THE TIP BROKE OFF INSIDE THE PATIENT. THE PHYSICIAN RETRIEVED THE BROKEN PIECE. THERE WAS NO PATIENT INJURY. THE PATIENT RECOVERED WITHOUT SEQUELA.

    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 IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION MODEL 7482A LOT# NHU172129V| IMPLANTED:| IMPLANTED:| PROGRAMMER MODEL 7436 LOT# NFU020234P| TUNNELING TOOL MODEL 3655 LOT# UNKNOWN| LEAD MODEL 3389 LOT# V092655| LEAD MODEL 3389 LOT# V092655| EXPLANTED:| EXTENSION MODEL 7482A LOT# NHU177228V| EXPLANTED: