BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE PUMP

    MDR report key: 3071583 · Received April 22, 2013

    Report

    Report Number
    3007566237-2013-01389
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    March 26, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8781, LOT# 0206291993. PRODUCT TYPE: CATHETER. (B)(4). ONLY THE ANCHOR DEPLOYMENT TOOL AND THE DETACHED ANCHOR WERE RETURNED. ANALYSIS OF THE ANCHOR REVEALED THE ANCHOR DID NOT PROPERLY DETACH FROM THE ANCHOR DEPLOYMENT TOOL. SIGNIFICANT TEARING WAS OBSERVED ON ONE END, AND REMNANTS OF SILICONE WERE SEEN ATTACHED TO THE HYPOTUBE OF THE ANCHOR DEPLOYMENT TOOL. THE ANOMALY SEEN WAS RELATED TO SILICONE BLOCKING THAT OCCURRED BETWEEN THE INTERACTION OF THE ANCHOR AND THE HYPOTUBE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, WHEN THE SPINAL CATHETER WAS FIXED DURING AN IMPLANT PROCEDURE, THE ANCHOR WAS NOT EASILY PULLED OUT OF THE ANCHOR DISPENSER EVEN THOUGH THE PROCEDURE WAS PROGRESSED ACCORDING TO THE SURGERY GUIDE. AFTER THE ANCHOR WAS PULLED OUT BY SLIDING WITH MUCH FRICTION, IT WAS DISTORTED. SOMETHING LIKE AN ANCHOR WAS ATTACHED TO THE METAL PART OF THE ANCHOR DISPENSER. IT WAS NOT REPORTED WHY THE CATHETER WAS FIXED. NO PATIENT SYMPTOMS WERE REPORTED. THE MEDICATION USED WITHIN THE SYSTEM WAS GABALON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171293 UNKNOWN IMPLANTABLE PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention