BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE LEAD EXTENSION, 30 CM

    MDR report key: 1790854 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01629
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    June 11, 2008
    Report Date
    June 19, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 2 OF 2. EVALUATION - 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. EXTENSION RETURNED INCOMPLETE AND COULD NOT BE FUNCTIONALLY TESTED. ALL WIRES WERE BROKEN FROM SOME OVERSTRESS. EXTENSION PASSED LEAD PULL TEST FOR RETENTION. 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 2 OF 2. REF MFR'S REPORT: 1627487-2010-01621. THE PT RECEIVED HIS SCS SYSTEM CONSISTING OF AN IPG, 2 PERCUTANEOUS LEADS AND 2 EXTENSIONS ON (B)(6) 2008. IT WAS REPORTED THAT THE PT LOST STIMULATION THE DAY FOLLOWING IMPLANT. WHEN HE TURNED ON HIS IPG, IT WOULD RAMP UP AND SHUT OFF. FLUOROSCOPY SHOWED THAT THE EXTENSIONS HAD PULLED OUT OF THE IPG HEADER. THE EXTENSIONS WERE REPLACED WITH LONGER EXTENSIONS ON (B)(6) 2008. THE LEADS REMAINED INTACT AND WERE REUSED. THE EXPLANTED EXTENSIONS WERE RETURNED TO ANS FOR ANALYSIS. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE LEAD EXTENSION, 30 CM SPINAL CORD STIMULATION EXTENSION LGW ADVANCED NEUROMODULATION SYSTEMS 3383 85241

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention