BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1944751 · Received December 15, 2010

    Report

    Report Number
    1627487-2010-03032
    Event Type
    Injury
    Date Received
    December 15, 2010
    Date of Event
    August 13, 2010
    Report Date
    September 19, 2010
    Manufacturer
    ST. JUDE MEDICAL -NEUROMODULATION DIV.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD: DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECS 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. THIS MDR IS BEING SUBMITTED PAST THE 30 DAY REPORTING REQUIREMENT AS PART OF A RETROSPECTIVE REVIEW INITIATED IN RESPONSE TO AN FDA INSPECTION. WE ARE SUBMITTING THIS MDR AS THE RESULT OF A RE-EVALUATION OF OUR MDR REVIEW PROCESS. 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 (SEE MFR REPORT # 1627487-2010-03033 FOR DEVICE 2 OF 2). THE PT WAS IMPLANTED WITH TWO TRIAL LEADS ON (B)(6) 2010. IT WAS REPORTED THAT DURING THE PROCEDURE, THE PT MOVED AND THE NEEDLE PUNCTURED THE DURA. THE PHYSICIAN PERFORMED A BLOOD PATCH IN THE OPERATING ROOM. FOLLOWING THE SURGERY, THE PT COMPLAINED OF A HEADACHE THAT REPORTEDLY CONTINUED FOR THE NEXT TWO DAYS. ON (B)(6) 2010, THE PHYSICIAN REMOVED THE TRIAL LEADS AND PERFORMED A SECOND BLOOD PATCH. THE LEADS WERE DISCARDED AND WILL NOT BE RETURNED TO THE MFR FOR EVAL. F/U ON THE PT FOUND THAT SHE IS DOING WELL AND THAT HER HEADACHE HAS SUBSIDED.

    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. 3086 3121666

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention