BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3142153 · Received May 29, 2013

    Report

    Report Number
    1627487-2013-08156
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2013-08155. IT WAS REPORTED THE PATIENT'S IPG (IMPLANTABLE PULSE GENERATOR) WAS INOPERABLE AND SHE WAS EXPERIENCING POCKET HEATING OCCASIONALLY WHICH WAS UNRELATED TO CHARGING. THE PATIENT HAD TWO SYSTEMS AND IT WAS UNKNOWN WHICH IPG HAD THE ISSUE. THE PATIENT WAS TO CONSULT WITH HER PHYSICIAN ABOUT THE IPG REPLACEMENT WITH A NON-RECHARGEABLE TYPE. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237087 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3536591

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention SCS LEAD, MODEL 3189 (2)| IMPLANT DATE: