BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3110914 · Received May 8, 2013

    Report

    Report Number
    1627487-2013-06266
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 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 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 MFR REPORT: 1627487-2013-06265. IT WAS REPORTED THE PATIENT WAS GOING TO HAVE HER IPG POCKET RELOCATED DUE TO PAIN WHEN SHE SAT DOWN. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2013. DURING THE PROCEDURE IT WAS DISCOVERED THE LEAD SITE WAS INFECTED. THE ENTIRE SYSTEM WAS REMOVED AND THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS. FOLLOW UP INFORMATION IDENTIFIED THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202451 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3416657

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention