BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA SURGICAL PADDLE LEAD

    MDR report key: 1880265 · Received October 19, 2010

    Report

    Report Number
    1627487-2010-03016
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 24, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL, 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. 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 HIS SCS SYSTEM, INCLUDING A PADDLE LEAD, ON (B)(6) 2010. TWO MONTHS POST-OPERATIVE, THE PT REPORTED FEELING NUMBNESS IN HIS BODY SINCE IMPLANT. A REVIEW OF THE SURGICAL RECORDS FOUND THAT SURGEON USED A DURAL SEPARATOR TO PLACE THE LEAD. F/U ON THE PT FOUND THAT THE REPORTED NUMBNESS HAS SUBSIDED. THE SCS SYSTEM WILL REMAIN IMPLANTED. NO ADDITIONAL INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA SURGICAL PADDLE LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION 3228 2885144

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention