BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE TRIPOLE 16 LEAD, 60CM

    MDR report key: 1790875 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01331
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    December 11, 2008
    Report Date
    December 11, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 1 OF 2. 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. LEAD FAILS CONTINUITY TESTING. LEAD SEGMENT HAS SOME DAMAGE AND THE PADDLE HAS ONE WIRE BROKEN. 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 1 OF 2. REFERENCE MFR REPORT # 1627487-2010-01335. THE PT RECEIVED HIS SCS SYSTEM CONSISTING OF AN IPG AND A PADDLE LEAD ON (B)(6) 2008. IT WAS REPORTED THAT THE PT EXPERIENCED A LOSS OF STIMULATION A FEW MONTHS LATER FOLLOWING A TIME WHEN THE PT RECALLED BENDING OVER. AN X-RAY SHOWED THAT BOTH TERMINAL ENDS OF THE LEAD HAD PULLED OUT OF THE IPG HEADER. THE SYSTEM WAS EXPLANTED ON (B)(6) 2009. FOLLOW UP ON THE PT FOUND THAT NO FURTHER ISSUES HAVE BEEN REPORTED. THE IPG AND LEAD WERE RETURNED TO ANS FOR EVAL AND THE PT IS DUE TO RECEIVE ANOTHER SYSTEM. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE 16 LEAD, 60CM SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS 3219 171380

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention