BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEADS

    MDR report key: 1962669 · Received January 13, 2011

    Report

    Report Number
    1627487-2011-01051
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 16, 2010
    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
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: METHOD - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS - REVIEW OF THE DEVICE HISTORY RECORDS FOUND A NONCONFORMANCE; HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE AND PRODUCT WAS REPLACED AND RELEASED. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE FAILURE. THE LEADS WERE RETURNED CUT AND INCOMPLETE; THEREFORE, FUNCTIONAL TESTING COULD NOT BE PERFORMED. DISCOLORATION IN THE LEAD SEGMENTS WAS NOTED. 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

    REFERENCE MFR REPORT: 1627487-2011-01050. THE PT RECEIVED HIS SCS SYSTEM, INCLUDING AN IPG AND TWO PERCUTANEOUS LEADS (FROM THE SAME LOT), ON (B)(6) 2005. IT WAS REPORTED THAT THE LEADS WERE EXHIBITING INVALID IMPEDANCE MEASUREMENTS ON LEAD CONTACTS 14-16. THE LEAD CONTACTS WERE REPORTED AS NECESSARY TO PROVIDE PT WITH ADEQUATE STIMULATION COVERAGE. THE LEADS WERE EXPLANTED AND REPLACED WITH A SURGICAL LEAD. FOLLOWING THE EXPLANT PROCEDURE, THE PT REPORTED EXCELLENT STIMULATION COVERAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEADS SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3186 35737

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention