BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8

    MDR report key: 4091944 · Received August 27, 2014

    Report

    Report Number
    1627487-2014-26684
    Event Type
    Injury
    Date Received
    August 27, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 8, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    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: 1627487-2014-26685. IT WAS REPORTED THE PT IS NOT RECEIVING EFFECTIVE STIMULATION. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. X-RAYS WERE TAKEN AND SHOWED THE LEAD HAS MIGRATED. PT DENIES ANY TRAUMA OF FALLS. FOLLOW UP INFO IDENTIFIED THE SCS SYSTEM WAS EXPLANTED PER THE PT'S REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522511 LAMITRODE S8 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3286 4517839

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other SCS ANCHOR, MODEL 1194 (2)| IMPLANT DATE:| SCS IPG, MODEL 3788| IMPLANT DATE: