BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCLAIM 8

    MDR report key: 3850642 · Received May 29, 2014

    Report

    Report Number
    1627487-2014-02373
    Event Type
    Injury
    Date Received
    May 29, 2014
    Date of Event
    September 20, 2013
    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 INFO 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: 1627487-2014-02372. IT WAS REPORTED THE PT WAS EXPERIENCING SENSITIVITY IN HIS NECK AND THORACIC PAIN. THE PT HAD FALLEN ON THE BEACH PREVIOUSLY, BUT IT IS UNK IF THIS CAUSED THE REPORTED ISSUE. AN SJM REP MET WITH THE PT AND CONFIRMED THE PT HAD SEVERAL INVALID CONTACTS BUT WAS ABLE TO REPROGRAM THE PT IN ORDER TO GAIN EFFECTIVE STIMULATION. ON (B)(6) 2014 AN SJM REP WAS INFORMED THAT THE PT WAS HAVING HIS LEADS REPLACED DUE TO INVALID IMPEDANCE READINGS. THE LEADS WERE REPLACED AND EFFECTIVE STIMULATION COVERAGE WAS REPORTEDLY RESTORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317198 EXCLAIM 8 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3224 3325362

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other IMPLANT DATE:| SCS IPG: MODEL 3788