BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1910920 · Received November 23, 2010

    Report

    Report Number
    1627487-2010-03347
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 28, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: 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 INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 3. REFERENCE MFR. REPORT #S 1627487-2010-03346 AND 1627487-2010-03348. ON (B)(6) 2010, THE PATIENT WAS IMPLANTED WITH TWO PERCUTANEOUS LEADS IN THE OCCIPITAL AREA FOR CHRONIC HEADACHES. IT WAS REPORTED THAT THE IMPLANTING PHYSICIANS MADE SEVERAL UNSUCCESSFUL ATTEMPTS TO TUNNEL FROM THE IPG POCKET UP TO THE NECK. BLOOD AND TISSUE WERE OBSERVED ON THE FIRST TUNNELLING TOOL UTILIZED. AS A RESULT, THE TUNNELLING TOOLS FROM THE TWO LEAD KITS WERE UTILIZED TO PATH UP THE PATIENT'S BACK (ACROSS THE LUNGS) AND FORM THE PATIENT'S MID-BACK AREA TO THE NECK. FOLLOWING THE PROCEDURE, IT WAS DISCOVERED THAT THE PATIENT WAS ADMITTED TO ICU FOR A PUNCTURED LUNG. SHE REPORTEDLY HAD A SMALL PNEUMOTHORAX. FOLLOW-UP ON THE PATIENT FOUND THAT SHE IS RECOVERING WELL AND IS CURRENTLY RECEIVING EFFECTIVE STIMULATION. ALL OF THE ASSOCIATED TUNNELING DEVICES WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIV 3189 3136781

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention