BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3960966 · Received July 22, 2014

    Report

    Report Number
    1627487-2014-20063
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 2, 2014
    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

    CORRECTION/REMOVAL NUMBER: 1627487-05242011-002-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 PATIENT HAS NOT CHARGED HIS SCS IPG FOR AT LEAST 1.5 MONTHS AND NOW THE DEVICE IS INOPERABLE. THE SJM REPRESENTATIVE CONFIRMED THE ISSUE. A REPLACEMENT CHARGER DID NOT RESOLVED THE ISSUE. SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429072 EON MINI SCS IPG GZB ST. JUDE MEDICAL -NEUROMODULATION 3788 3071752

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other SCS LEAD, MODEL: 3219| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR, MODEL: 1192 (2)| IMPLANT DATE:| SCS LEAD, MODEL: 3186