BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE EXTENSION

    MDR report key: 2030950 · Received March 22, 2011

    Report

    Report Number
    1627487-2011-01283
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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

    DEVICE 6 OF 8. REFERENCE MFR REPORTS: 1627487-2011-01278, 01279, 01280, 01281, 01282, 01284 AND 01285. THE PT REC'D HIS SCS SYSTEM, INCLUDING TWO IPGS, FOUR PERCUTANEOUS LEADS, AND FOUR ANCHORS ON (B)(6) 2010. THE PT UNDERWENT AN EXPLANT AND REPLACEMENT OF TWO OF THE PERCUTANEOUS LEADS ON (B)(6) 2011 (REFERENCE MFR REPORTS: 1627487-2011-01286 AND 1627487-2011-01287). IT WAS REPORTED THAT THE PT DEVELOPED AN INFECTION AROUND THE LEAD INCISION SITE AFTER THE REVISION PROCEDURE. IT WAS REPORTED THAT THE PT HAD REMOVED HIS STAPLES PRIOR TO HIS APPOINTMENT WITH THE PHYSICIAN. AS A RESULT OF THE INFECTION, THE PHYSICIAN EXPLANTED THE PATIENT'S ENTIRE SYSTEM. CULTURE RESULTS SHOWED THAT THE PT HAD (B)(6). THE PT WAS ALLEGEDLY TREATED WITH INTRAVENOUS ANTIBIOTICS. FOLLOW UP ON THE PT FOUND THAT THE PT WAS DISCHARGED HOME AND IS RECOVERING FROM THE INFECTION. THE PHYSICIAN PLANS TO RE-IMPLANT THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE EXTENSION SPINAL CORD STIMULATION EXTENSION LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3386 3224685

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R