BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCLAIM 8

    MDR report key: 3931887 · Received June 20, 2014

    Report

    Report Number
    1627487-2014-23418
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 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 AN 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

    THE PATIENT HAS 2 LEADS (FROM THE SAME LOT) IMPLANTED AS PART OF HER SCS SYSTEM. IT WAS REPORTED THE PATIENT COULD NOT FEEL STIMULATION COVERAGE. DIAGNOSTIC TESTING REVEALED HIGH IMPEDANCE READING ON ALL LEAD CONTACTS. SUBSEQUENTLY, THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2014, WHERE HER LEADS WERE EXPLANTED AND REPLACED WITH NEW ONES. THE PATIENT REPORTED ADEQUATE STIMULATION COVERAGE POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364046 EXCLAIM 8 SCS GZB ST. JUDE MEDICAL - NEUROMODULATION 3224 3608316

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Other SCS EXTENSION: MODEL 3383 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788