BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8

    MDR report key: 3231414 · Received July 12, 2013

    Report

    Report Number
    1627487-2013-11023
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 20, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DHR FOUND A NONCONFORMANCE RELATED TO THE PRODUCT LOT. HOWEVER, THE INDIVIDUAL AFFECTED DEVICE WAS REWORKED AND ALL DEVICES WITHIN THE LOT MET ACCEPTANCE CRITERIA. THEREFORE, THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE COMPLAINT. 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 5 OF 5. REFERENCE MFR REPORTS # 1627487-2013-11019, 1627487-2013-11020, 1627487-2013-11021, 1627487-2013-11022. THE PT HAD TWO SCS SYSTEM (ONE WAS FOR OFF-LABEL USE). IT WAS REPORTED THE SCS SYSTEM FOR OFF-LABEL USE WAS EXPLANTED DUE TO AN INFECTION. SJM WAS MADE AWARE OF THE EVENT ON (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324651 LAMITRODE S8 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3286 3450400

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other