BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 2051324 · Received April 7, 2011

    Report

    Report Number
    1627487-2011-01345
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 9, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    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 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) 2009. IT WAS REPORTED THAT THE PT HAD NOT USED STIMULATION IN TWO MONTHS. SHE STATED THAT SHE HAD TURNED OFF HER SYSTEM. SHE REPORTED THAT HER STIMULATION HAD TURNED ON BY ITSELF TWICE AND SHE DID NOT BELIEVE THIS ISSUE WAS RELATED TO HER POSITION AT THE TIME. THE PT WAS SCHEDULED FOR A REPROGRAMMING SESSION. 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 3788 176441

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention