BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL 4 EXTENSION

    MDR report key: 1714356 · Received February 26, 2010

    Report

    Report Number
    1627487-2010-00059
    Event Type
    Malfunction
    Date Received
    February 26, 2010
    Date of Event
    January 27, 2010
    Report Date
    January 28, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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

    DEVICE 3 OF 4. (REFER TO MFR'S REPORT NUMBERS, 1627487-2010-0053 FOR DEVICE 1, 1627487-2010-0058 FOR DEVICE 2 AND 1627487-2010-00107 FOR DEVICE 4). IT WAS REPORTED, THAT DURING A LEAD REVISION SURGERY (DUE TO LEAD MIGRATION) THE LEADS CAME OUT OF THE IPG HEADER. THE DOCTOR TIGHTENED THE SCREW WHILE USING A WRENCH, BUT THE LEADS CONTINUED TO SLIP OUT OF THE DEVICE. THE LEADS FUNCTIONED PROPERLY BUT WERE DISCARDED AFTER THE FAILED ATTEMPT TO TIGHTEN THEM INTO THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL 4 EXTENSION SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3341 2753958

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other