BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXXESS

    MDR report key: 3900131 · Received May 28, 2014

    Report

    Report Number
    1627487-2014-15393
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    ST. JUDE MEDICAL ¿ NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    DEVICE 2 OF 5. REFERENCE MFR REPORT: 1627487-2014-15392. REFERENCE MFR REPORT: 1627487-2014-153934. REFERENCE MFR REPORT: 1627487-2014-15395. REFERENCE MFR REPORT: 1627487-2014-15396. IT WAS REPORTED THE PT'S PNS (OFF-LABEL) LEADS SHOWED INVALID IMPEDANCE READINGS ON NUMEROUS CONTACTS. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2014 AND THE LEADS WERE EXPLANTED AND REPLACED. INTRA-OPERATIVE TESTING REVEALED INVALID IMPEDANCE READINGS. THE PHYSICIAN OPENED THE IPG SITE AND INDICATED THE EXTENSION WERE SLIGHTLY PULLED OUT OF THE HEADER. THE EXTENSIONS AND IPG WERE EXPLANTED AND REPLACED. THE PT REPORTED EFFECTIVE STIMULATION COVERAGE POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315183 AXXESS SCS LEAD GZB ST. JUDE MEDICAL ¿ NEUROMODULATION 4156 R28270

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other