BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCLAIM 8

    MDR report key: 3810591 · Received May 6, 2014

    Report

    Report Number
    1627487-2014-23297
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    August 26, 2008
    Report Date
    April 16, 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 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 PATIENT WAS NEVER HAPPY WITH HER STIMULATION COVERAGE SINCE HER IMPLANT. IT WAS ALSO REPORTED THE PATIENT ATTEMPTED REPROGRAMMING ON MULTIPLE OCCASIONS, BUT TO NO AVAIL. AS A RESULT, THE PATIENT DISCONTINUED THE USE OF HER SCS SYSTEM IN 2010. F/U INFO REVEALED THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2014 WHERE THE IPG WAS REMOVED. HOWEVER, THE LEADS REMAIN IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271231 EXCLAIM 8 SCS LEAD GZB ST. JUDE MEDICAL, NEUROMODULATION 3225 113532

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other IMPLANT DATE:| SCS EXTENSION, MODEL 3382