BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8

    MDR report key: 2973685 · Received February 19, 2013

    Report

    Report Number
    1627487-2013-13310
    Event Type
    Injury
    Date Received
    February 19, 2013
    Date of Event
    October 22, 2012
    Report Date
    January 25, 2013
    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 INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND 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

    DEVICE 1 OF 3. REFERENCE MFR REPORT: 1627487-2013-13311 AND 1627487-2013-13312. THE PATIENT HAD THREE LEADS WITH DIFFERENT MODEL AND LOT NUMBERS, REPORTING ON ALL LEADS. IT WAS REPORTED THE PATIENT'S LEAD HAD MIGRATED. THE ISSUE WAS RESOLVED ON (B)(6) 2012. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72710 LAMITRODE S8 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3286 3690346

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT:| IMPLANT:| SCS ANCHOR: MODEL 1192 (2)