BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 4113049 · Received September 17, 2014

    Report

    Report Number
    1627487-2014-02658
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    August 24, 2014
    Report Date
    August 25, 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

    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

    IT WAS REPORTED THE PATIENT COMPLAINED OF LEG WEAKNESS AND URINE RETENTION DURING HIS SCS SYSTEM TRIAL PERIOD. THE PATIENT WAS BROUGHT TO THE OPERATING ROOM AND THE PHYSICIAN REMOVED THE PATIENT'S LEAD AND A BLOOD CLOT WAS FOUND. THE PHYSICIAN CLEANED AND RE-INSERTED THE LEAD. THE PATIENT DECIDED TO GO AHEAD AND HAVE THE IPG IMPLANTED AND PROCEED WITH THE PERMANENT PROCEDURE. FOLLOW-UP IDENTIFIED THE PATIENT'S LEG WEAKNESS HAS IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575275 PENTA SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 4562658

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other