BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI, SCS IPG

    MDR report key: 3441825 · Received October 23, 2013

    Report

    Report Number
    1627487-2013-18535
    Event Type
    Injury
    Date Received
    October 23, 2013
    Date of Event
    October 2, 2013
    Report Date
    October 2, 2013
    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 NUMBER: 1627487-070262012-002-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 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-18536. IT WAS REPORTED THE PT EXPERIENCED PAIN AT THE IPG SITE. DIAGNOSTIC TESTING WAS PERFORMED PRIOR TO THE PT UNDERGOING SURGICAL INTERVENTION AND LOW IMPEDANCE READINGS WERE OBSERVED ON SEVERAL LEAD CONTACTS. THE PHYSICIAN EXPLANTED AND REPLACED THE PT'S IPG AS WELL AS REPOSITIONED THE IPG POCKET SITE. INTRAOPERATIVE DIAGNOSTIC TESTING OF THE LEAD REVEALED IMPEDANCES VALUES WITHIN NORMAL LIMITS. THE PT REPORTED EFFECTIVE STIMULATION COVERAGE POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543178 EON MINI, SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3066212

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other SCS ANCHOR: MODEL 1192| IMPLANT: