BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON RECHARGEABLE IPG, 16-CHANNEL

    MDR report key: 1962689 · Received January 13, 2011

    Report

    Report Number
    1627487-2011-00081
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 16, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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) 2007. IT WAS REPORTED THAT HE IS EXPERIENCING HEATING AT THE IPG POCKET WHEN CHARGING. THE ALLEGED SENSATION IS SAID TO BEGIN SHORTLY AFTER RECHARGING IS INITIATED AND INTENSIFIES AS THE SESSION PROGRESSES. EFFORTS TO RESOLVE THIS MATTER WITH THE USE OF A REPLACEMENT CHARGING SYSTEM PROVED UNSUCCESSFUL. FOLLOW-UP ON THE PT ALSO FOUND THAT HE IS EXPERIENCING DIFFICULTY COMMUNICATING WITH THE IPG VIA THE REPLACEMENT CHARGING SYSTEM. AN APPOINTMENT HAS BEEN SCHEDULED WITH THE PHYSICIAN TO DISCUSS FURTHER INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON RECHARGEABLE IPG, 16-CHANNEL TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION DIVISION 3716 87081

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention