BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8 SURGICAL LEAD

    MDR report key: 1971627 · Received January 25, 2011

    Report

    Report Number
    1627487-2011-01087
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 4, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DEVICE HISTORY RECORDS FOUND A NONCONFORMANCE; HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE AND DID NOT AFFECT PRODUCT INTEGRITY AND WAS APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE FAILURE. BOTH OF THE LAMITRODE LEADS WERE RETURNED. DISCOLORATION WAS NOTED IN BOTH PADDLES AND LEAD SEGMENTS. LAMITRODE B WAS OBSERVED TO HAVE BEEN OVERSTRESSED APPROX 3 CM AWAY FROM THE TERMINAL END AND HAD SEPARATION BETWEEN THE ELECTRODES AND SPACERS AT THE TERMINAL END. LAMITRODE B FAILED CONTINUITY TESTING AS ALL CHANNELS MEASURED OPEN. LAMITRODE A PASSED FUNCTIONAL TESTING. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM 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. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MANUFACTURER REPORT: 1627487-2011-01088. THE PT RECEIVED HIS SCS SYSTEM, INCLUDING AN IPG AND TWO SURGICAL LEADS (FROM TWO SEPARATE LOTS), ON (B)(6) 2006. THE PT'S ORIGINAL IPG WAS REPLACED IN (B)(6) 2010 WITH A SMALLER MODEL IPG (REFERENCE MANUFACTURER REPORT: 1627487-2010-00372). IT WAS REPORTED THAT ONE OF THE PT'S LEADS EXHIBITED INVALID IMPEDANCE READINGS ON 5 LEAD CONTACTS; THE OTHER LEAD MEASURED NORMAL FOR IMPEDANCE LEVELS. THE PT HAD LOST STIMULATION. IT WAS REPORTED THAT THE PHYSICIAN EXPLANTED AND REPLACED BOTH OF THE LEADS. THE PHYSICIAN STATED THAT THE FORMER PHYSICIAN WHO PERFORMED THE IPG REPLACEMENT PROCEDURE IN (B)(6) 2010 DID NOT MAKE THE IPG POCKET SMALLER; THEREFORE, THE IPG WAS ABLE TO MOVE AROUND WHICH CAUSED KINKS IN THE LEAD WIRES. FOLLOW UP ON THE PT FOUND THAT THE PT REGAINED EFFECTIVE STIMULATION WITH THE NEW LEADS. THE EXPLANTED LEADS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE S8 SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3286 R50998

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention