BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4092217 · Received September 3, 2014

    Report

    Report Number
    1627487-2014-26704
    Event Type
    Injury
    Date Received
    September 3, 2014
    Date of Event
    August 4, 2014
    Report Date
    August 11, 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 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

    DEVICE #2 OF 2: REFERENCE MFR. REPORT: 1627487-2014-26694. IT WAS REPORTED THE PT IS NOT RECEIVING STIMULATION AFTER HE SUFFERED A FALL, HOWEVER PRIOR TO THE FALL HE WAS NOT RECEIVING EFFECTIVE STIMULATION. LEAD DIAGNOSTICS SHOWED MULTIPLE LOW IMPEDANCES. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. X-RAYS ARE PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535394 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 175768

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other