BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON RECHARGEABLE IPG

    MDR report key: 2152255 · Received June 22, 2011

    Report

    Report Number
    1627487-2011-01685
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 24, 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 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 RECEIVED HER SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2007, IT WAS REPORTED THAT THE PT RECEIVED A LOW IPG WARNING, AND HER CHARGER WILL NO LONGER LOCATE THE IPG. A NEW CHARGING SYSTEM WAS SENT TO THE PT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PT'S CONDITION AND/OR DEVICE STATUS WERE UNSUCCESSFUL. ACCORDING TO THE MANUFACTURER'S DEVICE REGISTRATION SYSTEM, THE IPG REMAINS IMPLANTED. NO FURTHER PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 69189

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention IMPLANTED:| SCS LEAD, MODEL: 3214