BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1895428 · Received November 4, 2010

    Report

    Report Number
    1627487-2010-03509
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 11, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: THE DEVICE HISTORY 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 INFORMATION 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 ((B)(6)) REC'D AN SCS SYSTEM INCLUDING A PERCUTANEOUS LEAD, ON (B)(6) 2010. DURING THE IMPLANT, THE DOCTOR INITIALLY ATTEMPTED TO INSERT THE LEAD AT T10; HOWEVER, THE PHYSICIAN NICKED THE PT'S DURA, CAUSING A WET TAP. THE DOCTOR PERFORMED A BLOOD PATCH; THEN, REINSERTED THE LEAD BETWEEN T8-T9. IMMEDIATELY FOLLOWING THE SURGERY, THE PT REPORTED NO ADVERSE SYMPTOMS FROM THE WET TAP. APPROX 3-4 HRS LATER, THE PT COMPLAINED THAT HER RIGHT LEG WAS VERY PAINFUL. A CT SCAN OF THE SCS SYSTEM SHOWED THAT THE TIP OF THE LEAD WAS LOCATED INTRA-DURAL. THE DOCTOR TOOK THE PT BACK TO THE OPERATING ROOM ON (B)(6) 2010 TO REPOSITION THE EXISTING LEAD VIA A LAMINECTOMY. F/U ON THE PT FOUND THE PT IS NO LONGER EXPERIENCING PARAPLEGIA AND THE SCS STIMULATION IS ABLE TO COVER HER PAIN. THE LEAD REMAINS IN USE AND NO PRODUCT RETURN IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 2865487

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R