BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 4091902 · Received August 27, 2014

    Report

    Report Number
    1627487-2014-26683
    Event Type
    Injury
    Date Received
    August 27, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 7, 2014
    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: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES RELATED TO THIS EVENT 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 INFO 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. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT EXPERIENCED AN INFECTION WHERE HER THORACIC WOUND DEHISCED. THE PT UNDERWENT AN IRRIGATION OF HER WOUND AND CULTURES WERE TAKEN. RESULTS ARE UNK. A PICC LINE WAS INSERTED AND INFECTIOUS DISEASE IS MONITORING THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522807 PENTA SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 4468719

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other IMPLANT DATE:| SCS IPT, MODEL 3788