BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCLAIM 8

    MDR report key: 2934647 · Received January 4, 2013

    Report

    Report Number
    1627487-2013-05048
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    September 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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

    REFERENCE MFR REPORT#: 1927487-2013-05047 IT WAS REPORTED THE PT'S SCS SYSTEM HAS NOT PERFORMED AS INTENDED SINCE (B)(6) 2012. THE PT PLANS TO HAVE THE SYS EXPLANTED. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5695 EXCLAIM 8 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3224 114619

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention