BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON C 16-CHANNEL IPG

    MDR report key: 2113697 · Received June 2, 2011

    Report

    Report Number
    1627487-2011-00753
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: RESULTS: THE IPG PASSED ALL FUNCTIONAL TESTING; HOWEVER, MULTIPLE BAL-SEAL SPRINGS WERE FOUND TO BE DAMAGED IN THE LOWER HEADER PORT. SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT # 1627487-2011-00754. THE PT'S SCS SYSTEM INCLUDED AN IPG AND SURGICAL LEAD. IT WAS REPORTED THAT SHE WAS RECEIVING INEFFECTIVE STIMULATION. SHE REPORTEDLY ONLY RECEIVED THERAPY FROM TWO LEAD CONTACTS. X-RAYS REVEALED THAT THE PT'S LEAD WAS TWISTED, AND THE DEVICE'S PLACEMENT WAS NOT OPTIMAL TO ACHIEVE ADEQUATE STIMULATION. IN AN EFFORT TO ENSURE EFFECTIVE THERAPY FOR THE PT, BOTH HER IPG AND LEAD WERE REPLACED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON C 16-CHANNEL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3688 3143565

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention