BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3926233 · Received June 2, 2014

    Report

    Report Number
    1627487-2014-01375
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    January 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    ST. JUDE MEDICAL ¿ NEUROMODULATION
    Product Code
    GZB
    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. 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, THE IPG IS INOPERABLE AND WILL NOT COMMUNICATE WITH ANY EXTERNAL DEVICES. FOLLOW-UP IDENTIFIED THE PATIENT FAILED TO RECHARGE THE DEVICE FOR APPROXIMATELY 5 MONTHS. AS A RESULT, HE HAS BEEN WITHOUT STIMULATION SINCE (B)(6) 2014. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2014. THE IPG WA EXPLANTED AND REPLACED. EFFECTIVE STIMULATION WAS ACHIEVED POSTOPERATIVELY. THE ISSUE IS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322168 EON MINI SCS IPG GZB ST. JUDE MEDICAL ¿ NEUROMODULATION 3788 2897066

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other IMPLANT DATE:| SCS LEAD, MODEL 3186