BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCLAIM 8 SURGICAL LEAD

    MDR report key: 2042031 · Received March 31, 2011

    Report

    Report Number
    1627487-2011-01328
    Event Type
    Injury
    Date Received
    March 31, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: 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. SJM 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. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MANUFACTURER REPORT: 1627487-2011-01327. THE PATIENT RECEIVED HIS SCS SYSTEM, INCLUDING AN IPG ON (B)(6) 2009 AND SURGICAL LEAD ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED AN INFECTION OF THE IPG POCKET SITE AND THE LEAD INCISION SITE. THE PHYSICIAN EXPLANTED THE PATIENT'S IPG AND LEAD ON (B)(6) 2011. IT WAS UNKNOWN WHETHER A CULTURE WAS TAKEN. FOLLOW UP ON THE PATIENT FOUND THAT HE WAS TREATED WITH INTRAVENOUS ANTIBIOTICS AND THE INFECTION WAS RESOLVING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE EXPLANTED DEVICES WILL NOT BE RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCLAIM 8 SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3225 2847821

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R