BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON RECHARGEABLE IPG

    MDR report key: 1990666 · Received February 8, 2011

    Report

    Report Number
    1627487-2011-01115
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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 ON (B)(6) 2006. IT WAS REPORTED THAT THE PT'S IPG WAS UNABLE TO COMMUNICATE WITH THE PROGRAMMER AND CHARGER. IT WAS REPORTED THAT THE PT HAD CEASED USING THE SYSTEM IN 2006 AND DID NOT RECHARGE THE IPG. THE PT HAD HER IPG EXPLANTED AND REPLACED ON (B)(6) 2011. THE IPG HAS NOT BEEN RETURNED TO THE MANUFACTURER. NO FURTHER INFORMATION IS AVAILABLE .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIV. 3716 49110

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention