BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI 16-CHANNEL RECHARGEABLE IPG

    MDR report key: 2200868 · Received August 8, 2011

    Report

    Report Number
    1627487-2011-03411
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    K072462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DEVICE HISTORY RECORD FOUND A NONCONFORMANCE; HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE AND DID NOT AFFECT PRODUCT INTEGRITY OR PRODUCT FUNCTIONALITY; THEREFORE, THE DEVICE WAS APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE FAILURE. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2011-03391.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI 16-CHANNEL RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3308512

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention