BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 2041059 · Received March 29, 2011

    Report

    Report Number
    1627487-2011-00423
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    February 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: 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. TWO LEADS WERE RETURNED. ONE OF THE DEVICES FAILED CONTINUITY TESTING AND WAS FOUND TO HAVE AN OPEN CHANNEL. THE OTHER LEAD PASSED ALL FUNCTIONAL 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

    DEVICE 1 OF 2. REFERENCE MFR. REPORT # 1627487-2011-00424. THE PT RECEIVED AN SCS SYSTEM ON (B)(6) 2010, INCLUDING TWO PERCUTANEOUS LEADS AND TWO LEAD ANCHORS. IT WAS REPORTED THAT SHE IS RECEIVING UNCOMFORTABLE STIMULATION AT THE ANCHOR SITE WHENEVER THERAPY IS INITIATED. A DIAGNOSTIC TEST WAS PERFORMED; HOWEVER, NO IMPEDANCE ISSUES WERE OBSERVED. SURGICAL INTERVENTION WAS UNDERTAKEN TO REPLACE THE PT'S LEADS AND ANCHORS AND EFFECTIVE STIMULATION WAS RECAPTURED AS A RESULT. FOLLOW-UP ON THE PT FOUND NO ADDITIONAL ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD KIT, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3186 3166289

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT: