BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 2023351 · Received March 16, 2011

    Report

    Report Number
    1627487-2011-00356
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 2011
    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
    TX, US
    Reporter Occupation
    OTHER

    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 PATIENT WAS IMPLANTED WITH AN IPG ON (B)(6) 2008. IT WAS REPORTED THAT HE WAS EXPERIENCING OVERSTIMULATION. PREVIOUS DIAGNOSTIC TESTS REVEALED INVALID IMPEDANCE READINGS FOR ONE OF THE PATIENT'S LEAD CONTACTS. SURGICAL INTERVENTION WAS UNDERTAKEN TO RECTIFY THIS MATTER. DURING THE PROCEDURE, THE LEAD EXHIBITED NORMAL IMPEDANCE READINGS WHEN TESTED INDEPENDENTLY. AS SUCH, THE PHYSICIAN REPLACED THE IPG AND EFFECTIVE STIMULATION WAS CAPTURED FOR THE PATIENT AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG, 16-CHANNEL RECHARGEABLE TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3788 172716

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention