BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON 16-CHANNEL RECHARGEABLE IPG

    MDR report key: 2133461 · Received June 15, 2011

    Report

    Report Number
    1627487-2011-03105
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 17, 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

    RESULTS - VISUAL INSPECTION OF THE IPG REVEALED IT WAS IN GOOD CONDITION AND HAD ONLY MINOR INSTRUMENTATION MARKS. FURTHER, THE IPG PASSED ALL TESTS ON THE AUTOTESTER AND SHOWED NORMAL DEVICE CHARACTERISTICS. 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

    THE PATIENT RECEIVED HER SCS SYSTEM INCLUDING A SURGICAL LEAD ON (B)(6) 2007. HOWEVER, THE SYSTEM WAS REMOVED DUE TO A CLAIM THAT "IT IS NOT WORKING". THE DEVICE WAS RETURNED ON (B)(6) 2011 AND FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON 16-CHANNEL RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 97361

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention IMPLANTED:| IMPLANTED:| IMPLANTED:| SCS LEAD: MODEL 3156 (2)| SCS EXTENSION: MODEL 2342 (2)| SCS EXTENSION: MODEL 3341 (2)