BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3662790 · Received December 10, 2013

    Report

    Report Number
    1627487-2013-23367
    Event Type
    Injury
    Date Received
    December 10, 2013
    Date of Event
    November 13, 2013
    Report Date
    November 13, 2013
    Manufacturer
    ST. JUDE MEDICAL- NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL: 1627487-083+3023-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. 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

    IT WAS REPORTED THE PATIENT'S IPG IS INOPERABLE DUE TO THE PATIENT NOT CHARGING. IT WAS ALSO REPORTED THE PATIENT WILL UNDERGO SURGICAL INTERVENTION AT A LATER DATE TO HAVE HER IPG EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645236 EON MINI GZB ST. JUDE MEDICAL- NEUROMODULATION 3788 3158086

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)| SCS LEAD: MODEL 3186 (6)