BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3134016 · Received May 23, 2013

    Report

    Report Number
    1627487-2013-08143
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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

    THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. SJM HAS LIMITED INFORMATION 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 HAD NO RECHARGED THE IPG (IMPLANTABLE PULSE GENERATOR). ATTEMPTS WERE MADE TO COMMUNICATE USING THE CHARGERS BUT THE IPG WAS NON-RESPONSIVE. THE PHYSICIAN DECIDED TO DO AN IPG REPLACEMENT IN ORDER TO ADDRESS THE ISSUE. DURING THE PROCEDURE ON (B)(6) 2013, IT WAS REPORTED THE PT'S OXYGEN SATURATION DROPPED AND HENCE, THE PROCEDURE WAS ABANDONED WITHOUT EXPLANTING THE PRODUCT. FOLLOW-UP INFORMATION SUGGESTED THE PT HAD RECOVERED WITHOUT ANY ISSUE AND THE REPLACEMENT PROCEDURE WOULD BE UNDERTAKEN ONCE THE PT RECEIVED CARDIAC CLEARANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230028 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3103961

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)| SCS LEAD: MODEL 3186(2)| IMPLANT DATE: