BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON RECHARGEABLE IPG

    MDR report key: 2033521 · Received March 24, 2011

    Report

    Report Number
    1627487-2011-01305
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 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
    TX, 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, INCLUDING AN IPG, ON (B)(6) 2009. IT WAS REPORTED THAT THE PATIENT LOST STIMULATION. THE PHYSICIAN DECIDED TO EXPLANT AND REPLACED THE PATIENT'S IPG WITH A DIFFERENT MODEL ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT REGAINED STIMULATION AS A RESULT OF THE PROCEDURE. NO FURTHER ISSUES WERE REPORTED. THE EXPLANTED DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    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 2847732

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention