BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON RECHARGEABLE IPG

    MDR report key: 2040975 · Received March 25, 2011

    Report

    Report Number
    1627487-2011-01311
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    February 26, 2011
    Report Date
    February 26, 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
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    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 PT RECEIVED HER SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2011. IT WAS REPORTED THAT THE PT'S IPG WAS UNABLE TO COMMUNICATE WITH THE CHARGER. F/U ON THE PT FOUND THAT THE PROGRAMMER WAS ABLE TO COMMUNICATE WITH THE IPG. IT WAS REPORTED THAT THE ISSUE WAS POSSIBLY RELATED TO THE IPG NOT LAYING FLAT IN THE POCKET. THE PHYSICIAN REVISED THE IPG POCKET SITE ON (B)(6) 2011; HOWEVER, POSTOPERATIVELY THE IPG WAS STILL UNABLE TO COMMUNICATE WITH THE CHARGER. A REPLACEMENT CHARGER ALLEGEDLY RESOLVED THE ISSUE. 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 DIVISION 3716 3185103

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention