BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EEEP BRAIN STIMULATION LEAD

    MDR report key: 1032198 · Received April 21, 2008

    Report

    Report Number
    6000153-2008-02110
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 24, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    DURING THE STAGE 1, IMPLANT PROCEDURE THE PHYSICIAN INDICATED APPROPRIATE PLACEMENT OF THE ACCESSORY COVER AND BOOT ONTO THE PROXIMAL LEAD CONNECTOR. ONE WEEK LATER, THE LEAD CONNECTOR POCKET WAS OPENED FOR STAGE 2, SYSTEM PLACEMENT; INSPECTION FOUND THE BOOT DETACHED FROM THE LEAD AND FROM THE ACCESSORY COMPONENT COVER. THE SURGEON EXPERIENCED DIFFICULTY DURING RETRIEVAL OF THE PROXIMAL LEAD CONNECTOR FROM THE POCKET. VISUAL EXAM OF THE CONNECTOR DETECTED THE NUMBER THREE CONTACT WAS DAMAGED AND BENT AT A 90 DEGREE ANGLE; THE INTERNAL CONDUCTOR WIRES HAD BEEN FRAYED AND WERE EXPOSED FROM THE INSULATION MATERIAL. ATTEMPTS TO CONNECT THE DAMAGED LEAD TO THE EXTENSION PRODUCT WERE INITIALLY UNSUCCESSFUL. INTRA-OPERATIVE IMPEDANCE VALUES HAD BEEN WITHIN ACCEPTABLE LIMITS, EXCEPT FOR THE NUMBER THREE ELECTRODE (EXACT IMPEDANCE READINGS WERE NOT REPORTED), WHICH HAD INDICATED AN OPEN CIRCUIT. THE NUMBER THREE CONTACT WAS REMOVED (CUT OFF), FROM THE LEAD BY THE SURGEON AND THE EXTENSION PRODUCT CONNECTED TO THE LEAD DEVICE AND THE CASE WAS COMPLETED. NO PATIENT SYMPTOMS HAD BEEN ATTRIBUTED TO THE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEEP BRAIN STIMULATION LEAD MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 3387S V082506

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention EXTENSION MODEL 7482 LOT# NHU167409V| IMPLANTED:| IMPLANTED:| LOT# NFW146917H| IMPLANTABLE NEURO STIMULATOR MODEL 7426| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER MODEL UNK LOT# UNK