BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL LEAD EXTENSION

    MDR report key: 1870751 · Received September 29, 2010

    Report

    Report Number
    1627487-2010-01721
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    August 23, 2007
    Report Date
    August 28, 2007
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 SPECIFICATIONS AND NO ANOMALIES WERE FOUND. WIRES BROKEN. FAILS CONTINUITY TEST. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. (B)(4). 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 4 OF 4. REFERENCE MFR REPORTS: 1627487-2010-01758, 1627487-2010-01759 & 1627487-2010-01760. THE PT RECEIVED HER SCS SYSTEM INCLUDING THREE PERCUTANEOUS LEADS (FROM TWO SEPARATE LOTS), ONE DUAL LEAD EXTENSION AND AN IPG ON (B)(6) 2007. IT WAS REPORTED THAT DUE TO A LEAD FRACTURE, ONE OF THE LEADS, AN EXTENSION AND THE IPG WERE EXPLANTED AND REPLACED. AS THE LOT NUMBER FOR THE FRACTURED LEAD WAS NOT PROVIDED BY THE PHYSICIAN, A REPORT FOR EACH LEAD IS INCLUDED. F/U ON THE PT FOUND NO FURTHER ISSUES REPORTED. THE EXPLANTED PRODUCTS WERE RETURNED FOR ANALYSIS. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL LEAD EXTENSION SPINAL CORD STIMULATION LEAD EXTENSION LGW ADVANCED NEUROMODULATION SYSTEMS 3341 67105

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention