BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8

    MDR report key: 2792047 · Received October 12, 2012

    Report

    Report Number
    1627487-2012-06556
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    October 25, 2011
    Report Date
    September 18, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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 2 OF 2. REFERENCE MFR REPORT: 1627487-2012-06555. IT WAS REPORTED THE PT HAS BEEN EXPERIENCING INADEQUATE COVERAGE. IT WAS ALSO REPORTED THE PT HAS BEEN EXPERIENCING RIB STIMULATION. REPROGRAMMING ATTEMPTS WERE UNSUCCESSFUL. X-RAYS WERE TAKEN AND REVEALED ONE OF THE PT'S LEADS HAS MIGRATED. THE PT'S DOCTOR BELIEVES SCAR TISSUE MAY HAVE CAUSED THE LEAD TO MIGRATE. THE PT WILL BE REFERRED TO A DOCTOR TO UNDERGO SURGICAL INTERVENTION ON A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE S8 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3286 3473594

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention IMPLANTED:| IMPLANTED:| SCS ANCHORS: MODEL 1192 (2)| SCS IPG: MODEL 3716