BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3012138 · Received March 13, 2013

    Report

    Report Number
    1627487-2013-06058
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 21, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-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: 1627487-12192011-003-R, 1627487-05242011-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION AND 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 PT CANNOT LOCATE THE IPG WITH EITHER THE CHARGER OR THE PT PROGRAMMER. THE FIELD REP MET WITH THE PT AND CONFIRMED THE IPG CANNOT BE LOCATED. THE PT CANNOT REMEMBER WHEN WAS THE LAST TIME SHE CHARGED OR USED HER IPG. AN APPOINTMENT HAS BEEN SCHEDULED WITH THE PT'S PHYSICIAN TO DETERMINED THE NEXT COURSE OF ACTION. F/U IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106490 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2880336

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3186(X2)