BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON RECHARGEABLE IPG, 16-CHANNEL

    MDR report key: 2080520 · Received April 22, 2011

    Report

    Report Number
    1627487-2011-00559
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 28, 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 PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT RECEIVED AN SCS SYSTEM INCLUDING AN IPG ON (B)(6) 2009. IT WAS REPORTED THAT THE PT IS WITHOUT STIMULATION AND HAS OBSERVED THE LOW BATTERY WARNING FOR HER IPG. SHE IS ALSO UNABLE TO COMMUNICATE WITH THE DEVICE VIA THE CHARGING SYSTEM. IN AN EFFORT TO RESOLVE THIS MATTER, A REPLACEMENT CHARGING SYSTEM WAS SHIPPED TO THE PT. F/U ON THIS ISSUE FOUND THAT THE ALLEGED PROBLEM PERSISTS WITH THE USE OF THE NEW CHARGING SYSTEM. AS SUCH, SURGICAL INTERVENTION WILL BE UNDERTAKEN AT A LATER DATE TO REPLACE THE PT'S IPG.

    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 97740

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention