BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE 8 LEAD EXTENSION, 30 CM

    MDR report key: 1790806 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01582
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    April 9, 2008
    Report Date
    April 10, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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. BOTH EXTENSIONS HAVE ALL WIRES BROKEN IN THE HEADERS. THE LEAD PULL TEST WAS PERFORMED ON BOTH EXTENSION HEADERS AND BOTH PASSED. BOTH EXTENSIONS HAVE BEEN SUBJECTED TO EXTREME OVER STRESS. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. THIS MDR IS BEING SUBMITTED PAST THE 30 DAY REPORTING REQUIREMENT AS PART OF A RETROSPECTIVE REVIEW INITIATED IN RESPONSE TO AN FDA INSPECTION. A RETROSPECTIVE REVIEW OF THE COMPLAINT RECORD DETERMINED THAT ANS MISINTERPRETED THE MDR REGULATIONS IN THIS INSTANCE. ANS HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. ANS DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED HIS SCS SYSTEM CONSISTING OF AN IPG, 2 PERCUTANEOUS LEADS AND 2 EXTENSIONS ON (B)(6) 2008. SINCE IMPLANT, IT WAS REPORTED THAT LEAD IMPEDANCE TESTING HAS SHOWN VARYING LEAD IMPEDANCES. REPROGRAMMING RESOLVED THE ISSUE. HOWEVER, ON (B)(6) 2008 IT WAS REPORTED THAT THE PATIENT EXPERIENCED A COMPLETE LOSS OF STIMULATION. REPROGRAMMING THIS TIME DID NOT RESOLVE THE ISSUE. AN X-RAY SHOWED THAT 1 LEAD HAD PULLED COMPLETELY OUT OF THE HEADER AND THE OTHER LEAD HAD PULLED HALF WAY OUT, WITH ONE CONTACT REMAINING IN THE IPG. ON (B)(6) 2008, IT WAS REPORTED THAT THE EXTENSIONS WERE BROKEN AND THEREFORE REPLACED. THE EXISTING IPG AND LEADS REMAINED IMPLANTED AND THE SYSTEM WAS REPORTED TO BE FUNCTIONING PROPERLY. THE EXPLANTED EXTENSIONS WERE RETURNED TO ANS FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE 8 LEAD EXTENSION, 30 CM SPINAL CORD STIMULATION EXTENSION LGW ADVANCED NEUROMODULATION SYSTEMS 3383 84242

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention