BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEEP BRAIN SIMULATION LEAD

    MDR report key: 1031331 · Received April 18, 2008

    Report

    Report Number
    6000153-2008-02054
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 21, 2008
    Report Date
    March 21, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF FINAL DEVICE ANALYSIS WERE NOT COMPLETE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN PRODUCT EVAL HAS BEEN COMPLETED. REVIEW OF PHOTOGRAPHS OF THE ACTUAL DEVICE FROM THE REPORTED EVENT SHOWS THE LEAD COATING (INSULATION MATERIAL), WAS DAMAGED. THE IMAGE DEPICTS OUTER INSULATION MATERIAL THAT HAS FRACTURED OR PEELED FROM THE CONDUCTOR WIRES, THE DAMAGE WAS LOCATED PROXIMAL TO THE FIRST ELECTRODE CONTACTS NEAR THE DISTAL TIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INSULATION DAMAGE WAS DETACHED BY THE SURGEON DURING LEAD PLACEMENT. DEGRADATION OF THE OUTER INSULATION MATERIAL HAD BEEN NOTED PRIOR TO CONNECTION OF THE LEAD TO THE EXTENSION PRODUCT. THE LEAD WAS REPLACED DURING THE CASE WITH NO INJURY OR PT SYMPTOMS ATTRIBUTED TO THE EVENT. SUBSEQUENTLY THE PT WAS IMPLANTED WITH A PULSE GENERATOR (DATE UNK) AND HAS RECEIVED ADEQUATE STIMULATION THERAPY CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN SIMULATION LEAD MHY MEDTRONIC PUERTO RICO OPERATIONS CO 3387 V091112

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention