BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3001507 · Received March 5, 2013

    Report

    Report Number
    1627487-2013-10077
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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 PT ((B)(6)) WAS NO LONGER RECEIVING EFFECTIVE COVERAGE IN HIS/HER RIGHT LEG. ON (B)(6) 2013, THE PHYSICIAN REVISED THE POSITION OF THE SCS LEAD FROM SLIGHTLY LEFT OF MIDLINE AT T8-T9 TO SLIGHTLY RIGHT OF MIDLINE. THE PROCEDURE TOOK 3 HOURS TO COMPLETE. LATER THAT EVENING, IT WAS REPORTED, THE PT COULD NOT MOVE HIS/HER LEFT LEG. THE PT WAS BROUGHT BACK INTO SURGERY WHERE THE PHYSICIAN REMOVED A HEMATOMA (EXACT LOCATION UNK). THE PT WAS ADMITTED TO THE HOSP. ON (B)(6) 2013, THE PT WAS STILL UNABLE TO MOVE HIS / HER LEFT LEG. IT WAS REPORTED ON (B)(6) 2013, THE PT HAD ALMOST FULLY RECOVERED FROM THE PARALYSIS WITH A 10% DEFICIT REMAINING. THE PT HAS SINCE BEEN RELEASED FROM THE HOSP. THE PT HAS A HISTORY OF SEVERE BACK TRAUMA THAT OCCURRED IN 2009. AS A RESULT, THE PT HAS NEEDED A WHEELCHAIR OR CRUTCHES. IT WAS NOTED THE PT'S LEFT LEG HAS ALMOST RETURNED TO THE CONDITION IT WAS IN PRIOR TO THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93642 PENTA SCS LEAD GZB ST JUDE MEDICAL - NEUROMODULATION 3228 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R IMPLANT DATE:| SCS IPG: MODEL 3688