BEUDAMED
    FDA Adverse Event Death Summary report: N

    EON MINI

    MDR report key: 3150522 · Received May 30, 2013

    Report

    Report Number
    1627487-2013-04655
    Event Type
    Death
    Date Received
    May 30, 2013
    Date of Event
    March 24, 2013
    Report Date
    May 6, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION/REMOVAL NUMBER: 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. 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

    IT WAS REPORTED BY A FAMILY FRIEND THE PT HAD PASSED AWAY. THE CAUSE OF THE DEATH WAS NOT PROVIDED. AN ATTEMPT WAS MADE TO CONTACT THE PHYSICIAN'S OFFICE TO DETERMINE THE CAUSE OF DEATH; HOWEVER, THE OFFICE HAD NO INFORMATION. A REVIEW OF THE DEVICE MFR'S SYSTEM DID NOT FIND ANY PREVIOUS COMPLAINTS REGARDING THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237980 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2844881

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death SCS ANCHOR, MODEL 1194 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD, MODEL 3186 (2)