BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 1871023 · Received October 8, 2010

    Report

    Report Number
    1627487-2010-02631
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 8, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: UPON VISUAL INSPECTION, PRE-DECONTAMINATION REVEALED, SLOTTED ANCHOR INSERTED INTO THE NON-TAGGED LEAD, ONE COMPLETE DUAL LEAD. NO ANOMALIES NOTED. POST DECONTAMINATION REVEALED LEAD WAS RETURNED WITH A SLOTTED ANCHOR. LEAD HAS ELECTROCAUTERY INSTRUMENTATION DAMAGE ON THE LEAD SEGMENT APPROXIMATELY 2.5CM AWAY FROM THE PADDLE. AS RECEIVED THE LEAD HAS CHANNEL 1 ELECTRODE MISSING. TESTING REVEALS THAT CHANNEL 5 AND 6 ARE OPEN. VISUAL SHOWS THAT BOTH WIRES HAVE BEEN CUT IN THE LEAD SEGMENT APPROXIMATELY 15CM AWAY FROM THE LEAD PADDLE. FUNCTIONAL TESTING REVEALED, CONTINUITY TESTING FAIL. CHANNELS 5 AND 6 MEASURED AND OPENED. STRESS TESTING REVEALS THE LOCATION OF THE OPEN. CONCLUSION: COMPLAINT ABOUT "LEAD MIGRATION" CANNOT BE CONFIRMED THROUGH LAB TESTING. ANS HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. ANS DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. THE DOCTOR REVISED THIS PT DUE TO LEAD MIGRATION. THE DOCTOR PLANNED ON MOVING THE EXISTING LEAD, BUT INADVERTENTLY TOUCHED/DAMAGED THE LEAD WITH THE BOVIE. WHEN THE DOCTOR REMOVED THE LEAD FROM THE IPG HEADER, THE FIRST LEAD CONTACT REMAINED IN THE IPG. THE DOCTOR SUBSEQUENTLY REPLACED THE IPG AND REPLACED THE LEAD WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE 16 SPINAL CORD, IMPLANTED, (PAIN RELIEF) LGW ADVANCED NEUROMODULATION SYSTEMS 3219 2875858

    Patients

    Seq Age Sex Outcome Treatment
    1 Other