BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 44 SURGICAL LEAD

    MDR report key: 1629274 · Received March 10, 2010

    Report

    Report Number
    1627487-2010-00153
    Event Type
    Injury
    Date Received
    March 10, 2010
    Date of Event
    February 7, 2010
    Report Date
    February 8, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: DEVICE EVALUATION IS STILL UNDERWAY AND RESULTS NOT YET AVAILABLE. THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS 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 INFORMATION 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 3 OF 3. REFERENCE MANUFACTURER REPORT NUMBERS: 1627487-2010-00085 AND 1627487-2010-00152. THE PT RECEIVED HER SCS SYSTEM INCLUDING AN IPG AND 2 LEADS ON (B) (6) 2009. IT WAS REPORTED THAT AT POST-OPERATIVE FOLLOW UP THE PT EXHIBITED SIGNS OF WOUND SITE BREAKDOWN AT THE LEAD INSERTION SITE WHICH THEN REQUIRED SURGERY AND ANTIBIOTICS TO CORRECT. IT WAS REPORTED THAT ABOUT 2-3 WEEKS LATER THE PT WAS ADMITTED TO THE EMERGENCY ROOM WITH AN INFECTION AT THE SAME LOCATION AND WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. THE PHYSICIAN EXPLANTED THE SYSTEM ON (B) (6) 2010 AND DOES NOT HAVE PLANS TO REIMPLANT THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 44 SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3262 2836742

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention