BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 2051333 · Received April 7, 2011

    Report

    Report Number
    1627487-2011-01364
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 11, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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 PT REC'D HER SCS SYS, INCLUDING AN IPG, ON (B)(6) 2009. IT WAS REPORTED THAT THE PT LOST WEIGHT AND THE IPG MOVED NEAR HER TAILBONE. THE PT REPORTED THAT SHE IS STILL USING STIMULATION, BUT THE IPG IS UNCOMFORTABLE AND SORE AT THIS LOCATION. F/U ON THE PT FOUND THAT THE PT VISITED AN EMERGENCY ROOM DUE TO HER PAIN AT THE IPG LOCATION. THE PT REPORTED THAT SHE CONSULTED WITH AN ORTHOPEDIC SURGEON TO REVISE HER IPG, BUT THE PROCEDURE DATE HAS NOT BEEN SCHEDULED YET. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    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 2816188

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R