BEUDAMED
    FDA Adverse Event Other Summary report: N

    EON C 16-CHANNEL IPG

    MDR report key: 2163580 · Received June 9, 2011

    Report

    Report Number
    1627487-2011-00785
    Event Type
    Other
    Date Received
    June 9, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 11, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    THE PATIENT RECEIVED AN SCS SYSTEM INCLUDING A NON-RECHARGEABLE IPG ON (B)(6) 2010. IT WAS REPORTED THAT THE LOW BATTERY WARNING WAS OBSERVED ON THE PATIENT'S PROGRAMMER. IT WAS DETERMINED THAT THE WARNING WAS A RESULT OF BATTERY PASSIVATION, AND THE MESSAGE WAS SUCCESSFULLY CLEARED.

    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 3209306

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention SCS LEAD ANCHOR: MODEL 1192| SCS LEAD: MODEL 3186| IMPLANT: