BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 2092429 · Received May 2, 2011

    Report

    Report Number
    3007566237-2011-03192
    Event Type
    Malfunction
    Date Received
    May 2, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 14, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING AN IMPLANT PROCEDURE, THE HEALTH CARE PROVIDER (HCP) WAS TIGHTENING THE CONNECTOR BOOT ON A LEAD. THE HCP STATED THE TORQUE WRENCH DID NOT MAKE THE "CLICKING NOISE" INDICATING THE CONNECTOR BOOT IS PROPERLY TIGHTENED, AND AS A RESULT THE #3 ELECTRODE ON THE LEAD WAS DAMAGED. THE HCP DECIDED TO LEAVE THE LEAD IN PLACE, AS THE #3 ELECTRODE WOULD NOT BE USED IN PROGRAMMING. THE PATIENT RECOVERED WITHOUT SEQUELA.

    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 IMPLANTED:| LEAD: MODEL 3389, LOT# 0204919341| EXPLANTED: