BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE 8 PERCUTANEOUS LEAD

    MDR report key: 1762932 · Received June 30, 2010

    Report

    Report Number
    1627487-2010-01427
    Event Type
    Malfunction
    Date Received
    June 30, 2010
    Date of Event
    April 19, 2010
    Report Date
    April 19, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD: THE 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. ANS HAS LIMITED INFO RELATED TO THE PT'S MEDIAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. ANS DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. O (B)(6) 2009, THE PT WAS IMPLANTED WITH A SCS SYSTEM. ON (B)(6) 2010, THE PT LOST STIMULATION. THE PT WAS UNABLE TO INCREASE THE AMPLITUDE PAST PERCEPTION. ON (B)(6) 2010, THE SALES REP REPORTED THAT THE PT HAD AN X-RAY WHICH REVEALED THAT THE LEADS BACKED OUT OF THE EPIDURAL SPACE AND WERE BROKEN AT THE IPG SITE. THE DR SUBSEQUENTLY EXPLANTED AND REPLACED THE LEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE 8 PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3186 2781314

    Patients

    Seq Age Sex Outcome Treatment
    1 Other