BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE

    MDR report key: 3802474 · Received February 21, 2014

    Report

    Report Number
    1627487-2014-00077
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    December 13, 2013
    Report Date
    January 26, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES: RESULTS - THE COMPLAINT FOR "STYLET INSERTION PROBLEM" WAS CONFIRMED. AS RECEIVED, BOTH LAB STYLETS (STRAIGHT AND CURVE) USED TO RECREATE PATIENT SCENARIO ENCOUNTERED SOME RESISTANCE AROUND 56 CM FROM TERMINAL END, AND MOVING FORWARD. A VISUAL INSPECTION OF ONE CROSS SECTION THE LEAD FOUND THAT THE STYLET LUMEN WAS NOT UNIFORM AND HAD SOME NARROWING (THE SHAPE WAS OVAL TYPE RATHER THAN ROUND) WITH MAJORITY OF WIRES STRANDED ON ONE SIDE AND COULD CONTRIBUTE TO THE REPORTED ISSUE. 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

    THIS LEAD WAS INTENDED FOR IMPLANT IN (B)(6). DURING THE PROCEDURE, IT WAS REPORTED THE PHYSICIAN EXPERIENCED DIFFICULTY INSERTING THE STYLET TO FACILITATE POSITIONING OF THE LEAD. ATTEMPT TO OVERCOME THIS ISSUE WITH USE OF MULTIPLE STYLETS WERE UNSUCCESSFUL. AS SUCH, A NEW LEAD WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109988 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4204652

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK