BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 2133635 · Received June 16, 2011

    Report

    Report Number
    1627487-2011-01656
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2011-01657. THE PT (B)(6) RECEIVED HER SCS SYSTEM, INCLUDING AN IPG AND EXTENSION, ON (B)(6) 2010. IT WAS REPORTED THAT THE PT WAS TAKEN TO SURGERY TO REVISE THE POSITION OF THE IPG SITE. THE SURGEON OPENED THE IPG POCKET AND PULLED OUT THE EXTENSION FROM THE IPG HEADER BLOCK. IT WAS NOTED THAT THE VERY END LEAD CONTACT ON THE EXTENSION WAS MISSING. AN X-RAY WAS TAKEN, BUT IT DID NOT REVEAL THE MISSING LEAD CONTACT. THE PHYSICIAN DECIDED TO EXPLANT AND REPLACE BOTH THE IPG AND THE EXTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3165997

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention