BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE 3/4 PERCUTANEOUS LEADS

    MDR report key: 1871008 · Received October 8, 2010

    Report

    Report Number
    1627487-2010-02774
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 10, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL 2 OF 3. PLEASE SEE MFR REPORT# 1627487-2010-02750 FOR EVAL OF DEVICE 1 AND MFR REPORT# 1627487-2010-02775 FOR EVAL OF DEVICE 3. METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE ALSO REVIEWED. RESULTS: THE PRODUCT HAS NOT BEEN RETURNED SO NO ANALYSIS CAN BE PERFORMED. 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 MEDICAL 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 3. PLEASE SEE MFR REPORT # 1627487-2010-02750 FOR DEVICE 1 AND MFR REPORT # 1627487-2010-02775 FOR DEVICE 3. ON (B)(6) 2010, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. THE PT HAD AN INFECTION AT BOTH THE LEAD AND IPG SITES. CULTURES WERE TAKEN BUT THE RESULTS ARE UNK. THE PT WAS TREATED WITH KEFLEX AND THE ENTIRE SYSTEM WAS EXPLANTED ON (B)(6) 2010 AND DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE 3/4 PERCUTANEOUS LEADS SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS 3186 3117466

    Patients

    Seq Age Sex Outcome Treatment
    1 Other