BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 1940425 · Received December 20, 2010

    Report

    Report Number
    1627487-2010-03839
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    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
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED HER SCS SYSTEM ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT HER IPG POCKET SITE AFTER SHE WAS ASSAULTED. THE PATIENT STATED SHE NEEDED TO RECHARGE HER IPG MORE FREQUENTLY. THE IPG POCKET WAS REVISED, BUT AFTERWARD THE IPG WAS UNABLE TO COMMUNICATE WITH THE CHARGER. A REPLACEMENT CHARGER DID NOT RESOLVE THE ISSUE. FOLLOW UP ON THE PATIENT REPORTED THAT THE PATIENT'S IPG WAS EXPLANTED AND REPLACED ON (B)(6) 2010. THE EXPLANTED IPG WAS RETURNED TO THE MANUFACTURER FOR EVALUATION ON (B)(6) 2010. THE PATIENT REPORTED EFFECTIVE STIMULATION AFTER THE REPLACEMENT PROCEDURE.

    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 DIVISION 3788 2929931

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention