BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON RECHARGEABLE IPG, 16-CHANNEL

    MDR report key: 2092991 · Received April 14, 2011

    Report

    Report Number
    1627487-2011-00504
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    ST JUDE MEDICAL- NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 WAS IMPLANTED WITH AN IPG ON (B)(6) 2011. IT WAS REPORTED THAT SHE IS HAVING DIFFICULTY MAINTAINING COMMUNICATION BETWEEN THE IPG AND THE CHARGING SYSTEM. IN AN EFFORT TO RESOLVE THIS MATTER, A REPLACEMENT CHARGING SYSTEM WAS SHIPPED TO THE PATIENT. FOLLOW-UP ON THIS ISSUE FOUND THAT THE REPORTED PROBLEM PERSISTS WITH USE OF THE NEW CHARGING SYSTEM. NO FURTHER INFORMATION IS AVAILABLE.

    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 3145869

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention