BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCUTANEOUS TRIAL LEAD

    MDR report key: 1432255 · Received July 31, 2009

    Report

    Report Number
    1627487-2009-00022
    Event Type
    Injury
    Date Received
    July 31, 2009
    Date of Event
    July 6, 2009
    Report Date
    July 9, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT # 2790275. EVALUATION: DEVICE HISTORY RECORDS AND STERILIZATION RECORDS WERE REVIEWED, NO ANOMALIES WERE FOUND. RESULTS: ALL RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS. CONCLUSION: DEVICES NOT RETURNED. THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. ANS 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. ANS DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    ANS WAS ADVISED IN 2009, THAT THE PATIENT WAS IMPLANTED WITH TWO PERCUTANEOUS TRIAL LEADS ONE MONTH PRIOR, AND THAT THE LEADS WERE EXPLANTED THE FOLLOWING MONTH, DUE TO AN INFECTION AT THE IMPLANT SITE. ANS WAS INFORMED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON THE SAME DAY, FOR IV ANTIBIOTICS. IT WAS REPORTED THAT THE PHYSICIAN STATED THE PATIENT WAS DOING FINE. IT WAS REPORTED THAT THE LEADS WERE DISCARDED BY THE HOSPITAL AND WILL NOT BE RETURNED TO ANS FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF RELEVANT INFORMATION IS PROVIDED TO ANS WITHIN THE NEXT 30 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUTANEOUS TRIAL LEAD SPINAL CORD STIMULATION LEAD GZB ADVANCED NEUROMODULATION SYSTEMS, INC. 3086 2787298

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other