BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA SURGICAL LEAD

    MDR report key: 1892058 · Received October 26, 2010

    Report

    Report Number
    1627487-2010-03059
    Event Type
    Injury
    Date Received
    October 26, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 8, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: A REVIEW OF THE DHR FOUND A NONCONFORMANCE RELATED TO THE PRODUCT, HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE AND DID NOT AFFECT PRODUCT INTEGRITY OR PRODUCT FUNCTIONALITY AND WAS APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE FAILURE. AN INCOMPLETE LEAD SEGMENT WAS RETURNED TO THE MFR FOR ANALYSIS. VISUAL ANALYSIS FOUND A KINK ON THE LEAD SEGMENT OF CHANNELS 1-8 APPROX 3.4CM FROM THE PADDLE. THE LEAD PASSED ALL FUNCTIONAL AND STRESSED 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

    THE PT RECEIVED AN SCS SYSTEM, INCLUDING A SURGICAL LEAD AND AN IPG, ON 10/07/2010. PRIOR TO THE IMPLANT, THE PHYSICIAN ASSESSED THE IMPLANT SITE VIA A CT SCAN. DURING THE IMPLANT PROCEDURE, THE PT WAS REPORTEDLY UNDER GENERAL ANESTHESIA AND, SUBSEQUENTLY, NO INTRA-OPERATIVE TESTING WAS PERFORMED. THE PHYSICIAN USED A DURAL SEPARATOR FROM THE HOSPITAL'S STOCK TO PLACE THE LEAD. POST-OPERATIVE, THE PT REPORTED HE WAS NOT ABLE TO MOVE HIS LEGS. THE PT WAS TAKEN BACK TO SURGERY FOR AN EXPLORATORY PROCEDURE. THE PHYSICIAN WAS UNABLE TO FIND ANY ABNORMALITIES. THE PT UNDERWENT ANOTHER CT SCAN. AGAIN, NO ABNORMALITIES WERE FOUND. AS THE PARALYSIS WAS NOT LIFTING, THE SCS SYS WAS EXPLANTED AND NOT REPLACED 5 DAYS POST-IMPLANT. F/U ON THE PT INDICATED THERE WAS NO IMPROVEMENT SINCE EXPLANT AND HE REMAINS PARALYZED FROM THE WAIST DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3143271

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S