BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16C

    MDR report key: 2881498 · Received December 17, 2012

    Report

    Report Number
    1627487-2012-11835
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    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

    IT WAS REPORTED, THE PT WAS IN AUTOMOBILE ACCIDENT AND LOST STIMULATION COVERAGE IN HER LOWER BACK AREA. THE COVERAGE FOR BILATERAL LEG STIMULATION REMAINED EFFECTIVE. THE PHYSICIAN OPTED TO IMPLANT A NEW PERIPHERAL SCS SYSTEM RATHER THAN TO REPOSITION THE EXISTING LEAD. IT WAS REPORTED THE PT RECEIVED STIMULATION COVERAGE WITH THE NEW SCS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE 16C SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3214 2854803

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3716| SCS EXTENSION: MODEL 3383 (2)