BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3110733 · Received May 9, 2013

    Report

    Report Number
    1627487-2013-15627
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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'S LEAD INCISION SITE HAD COME APART APPROXIMATELY 1 INCH AT THE MIDLINE. THE PT WAS ALSO RUNNING A FEVER. THE PHYSICIAN SENT THE PT TO THE ER WHERE THE INCISION SITE WAS CLEANSED, A PICC LINE WAS PLACED AND ANTIBIOTICS ADMINISTERED. NO CULTURE WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205037 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3929382

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention IMPLANTED:| SCS IPG: MODEL 3788