BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 88C SURGICAL LEAD

    MDR report key: 1924446 · Received December 7, 2010

    Report

    Report Number
    1627487-2010-03455
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION 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. THE LEAD WAS RETURNED CUT AND INCOMPLETE. THE CUT WAS OBSERVED APPROX 12CM AWAY FROM THE LAMITRODE PADDLE. THERE WERE MULTIPLE SIGNS OF ELECTROCAUTERY INSTRUMENTATION DAMAGE ON THE LEAD SEGMENT. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. JSM HAS LIMITED INFO 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

    THE PT WAS IMPLANTED WITH A SURGICAL LEAD ON (B)(6) 2007. THE PATIENT'S IPG AND TWO EXTENSIONS WERE EXPLANTED ON (B)(6) 2010 DUE TO AN ALLEGED INFECTION (SEE MFR. REPORT #S 1627487-2010-03201, 1627487-2010-03202 AND 1627487-2010-03203). IT WAS THE PHYSICIAN'S INTENT TO LEAVE THE ORIGINAL SURGICAL LEAD IMPLANTED; HOWEVER, UPON VISUAL EXAMINATION OF THE DEVICE, IT ALSO WAS REPLACED ON (B)(6) 2010, DURING THE SURGICAL PROCEDURE TO REPLACE THE PATIENT'S IPG. FOLLOW-UP ON THE PT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 88C SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3289 64748

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention