BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STIMPILOT

    MDR report key: 2920704 · Received January 17, 2013

    Report

    Report Number
    1723170-2013-00034
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K954276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MANUFACTURE DATE IS PROVIDED.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. RMA ISSUED. REPLACEMENT PART SHIPPED TO THE SITE (B)(4) 2012. MEDTRONIC EVALUATION OF RETURNED SUSPECT COMMUNICATION CABLE FINDS A CONTINUITY TEST REVEALED AN INTERMITTENT CONNECTION AT PIN 1 OF THE 10 PIN LEMO CONNECTOR. FLEXING THE CABLE NEAR THIS CONNECTOR CAUSES THE INTERMITTENCE. ROOT CAUSE WAS FOUND TO BE ELECTRICAL AND IS DEEMED RELATED DIRECTLY TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT IF THE STIMPILOT CAMERA CABLE IS MOVED, OR WIGGLED, IN ANY WAY, THE CAMERA COMMUNICATION WILL CEASE AND THE CAMERA WILL BEGIN BEEPING. IT WAS CONFIRMED THAT THE CONNECTION TO THE CAMERA WAS VERY STABLE. A REPLACEMENT COMMUNICATION CABLE WAS REQUESTED. THERE WAS NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26359 STIMPILOT NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1