BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON C 16-CHANNEL IPG

    MDR report key: 2092663 · Received May 10, 2011

    Report

    Report Number
    1627487-2011-00632
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 11, 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

    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

    THE PT WAS IMPLANTED WITH AN IPG ON (B)(6) 2008. IT WAS REPORTED THAT THE PT'S IPG WAS REPLACED DUE TO BATTERY DEPLETION. SHE HAD ALLEGEDLY OBSERVED THE LOW BATTERY WARNING LAST SUMMER BEFORE TEMPORARILY SUSPENDING USE OF HER SCS SYSTEM. NO FURTHER COMPLICATIONS WERE REPORTED FOLLOWING THE IPG REPLACEMENT PROCEDURE.

    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 174853

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3228