BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 4

    MDR report key: 3890681 · Received June 3, 2014

    Report

    Report Number
    1627487-2014-02394
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 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 1 OF 2. REFERENCE MFR REPORT: 1627487-2014-02395. IT WAS REPORTED THAT PT IS NOT RECEIVING EFFECTIVE STIMULATION COVERAGE OF ALL OF HIS PAIN AREA. A SJM REPRESENTATIVE MET WITH THE PT. A DIAGNOSTICS OF THE PT'S SCS SYSTEM REVEALED MULTIPLE INVALID LEAD(S) CONTACTS. REPROGRAMMING DID NOT RESOLVE THE ISSUE. X-RAYS TAKEN DID NOT SHOW ANY ABNORMALITIES. SURGICAL INTERVENTION MAY BE UNDERTAKEN AT A LATER TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324895 LAMITRODE 4 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3254 2874233

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other IMPLANTED:| SCS IPG: MODEL 3788