BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3973083 · Received August 1, 2014

    Report

    Report Number
    3007566237-2014-02151
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    June 26, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MFR
    PMA / PMN Number
    H050003
    Removal / Correction Number
    Z-1190-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS A NEW IMPLANT CASE. IT WAS NOTED THAT THE PATIENT WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) ON (B)(6) 2014. IT WAS NOTED THAT DURING THE PROCEDURE OF REMOVAL OF THE BOOT FORM THE LEAD CAP. IT WAS NOTED THAT THE LAST CONTACT 3 OF THE LEAD WAS PULLED OUT WITH UN-COILING OF THE CONNECTING WIRE. IT WAS NOTED THAT IT WAS CAUSED BY THE FIXATION BETWEEN THE LEAD-CAP AND THE LEAD (BETWEEN CONTACT 3 AND 2 UNCOILED) DURING THE REMOVAL OF THE BOOT. IT WAS NOTED THAT THE DAMAGE WAS NOT SALVAGEABLE BUT TO CUT AND REMOVE THE LAST CONTACT. IT WAS NOTED THAT THE CLIENTS WERE NOT SATISFIED WITH THE CONNECTION DESIGN OF THE LEAD-CAP AND BOOT. IT WAS NOTED THAT THE DEVICE WAS USED WITH IN THE PATIENT. IT WAS NOTED THAT THERE WAS NO PATIENT DEATH OR INJURY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS A CASE OF PULL-OUT OF THE 3RD CONTACT WITH UN-COILING OF THE CONNECTING WIRE WITH THE CONTACT DURING THE CONNECTION OF THE LEAD TO EXTENSION ELECTRODE. IT WAS NOTED THAT THIS OCCURRED DURING THE REMOVAL OF THE BOOT FROM THE LEAD-CAP. THE LEAD-CAP HAD FIXED THE LEAD (BETWEEN CONTACT 3 AND 2 UNCOILED) DURING THE REMOVAL OF THE BOOT. IT WAS NOTED THAT THE DAMAGE WAS NOT SALVAGEABLE BUT TO CUT AND REMOVE THE 3RD CONTACT. IT WAS NOTED THAT THE LEAD-CAP, BOOT AND CONNECTION DESIGN WAS A LONG TERM EXISTING PROBLEM. IT WAS NOTED THAT THE DESIGN WAS FAULTY AND THE BOOT WAS ONLY FIXED BY FRICTION. IT WAS NOTED THAT THE PERMANENT ELECTRODES WERE FIXED BY SUTURE BY THE SURGEON. THE REPORTER STATED ¿IN THE LITERATURE, HIGH PERCENTAGE OF HARDWARE PROBLEMS AND COMPLICATIONS IS BECAUSE OF THIS FAULTY DESIGN.¿ ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE WAS LEFT IN THE PATIENT. IT WAS NOTED THAT THE PATIENT WAS USING THAT DEVICE FOR THERAPY. IT WAS NOTED THAT ALTHOUGH ONE CONTACT WAS NON-FUNCTIONING THE OTHER THREE CONTACTS WERE WORKABLE. IT WAS NOTED THAT THE PATIENT WAS IN THE PROGRAMMING STATE AND WAS ABLE TO RECEIVE THERAPY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT AFTER IMPLANTING 2 DEEP BRAIN STIMULATION (DBS) LEADS, THE LEAD CONTACT 3 IN ONE LEAD WAS BROKEN AND THEN CUT OFF BECAUSE THE NEUROSURGEON DID NOT LOSE THE SCREW WHEN REMOVING THE LEAD CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449634 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MFR MEDTRONIC NEUROMODULATION 3387-40

    Patients

    Seq Age Sex Outcome Treatment
    1