BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3150077 · Received May 30, 2013

    Report

    Report Number
    1627487-2013-04670
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    February 25, 2013
    Report Date
    May 3, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R 1
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL NUMBER: 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. RESULTS: THE COMPLAINT WAS CONFIRMED. PER THE EVENT DETAILS, THE PT DID NOT RECHARGE THE IPG FOR AN EXTENDED PERIOD BECAUSE SHE WAS PREGNANT. ANALYSIS CONFIRMED USER ERROR. 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 WAS 8 MONTHS PREGNANT AND HAD NOT BEEN USING THE SCS SYSTEM DURING HER PREGNANCY. THE PT WAS UNABLE TO COMMUNICATE WITH THE IPG USING THE EXTERNAL DEVICES. A REPLACEMENT CHARGING SYSTEM WAS SENT TO THE PT. F/U IDENTIFIED THE PHYSICIAN REPLACED THE IPG. IT WAS REPORTED THE PT RECEIVED STIMULATION POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237709 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 171786

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention IMPLANT:| SCS LEAD: MODEL 3186