BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 3850691 · Received May 21, 2014

    Report

    Report Number
    1627487-2014-26426
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 28, 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 INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AN 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

    IT WAS REPORTED, DURING REPROGRAMMING THE PATIENT WAS UNABLE TO USE HER SCS SYSTEM BECAUSE SHE WAS UNABLE TO INCREASE HER STIMULATION ABOVE A CERTAIN LEVEL WITHOUT THE STIMULATION DECREASING. DIAGNOSTIC TESTING REVEALED MULTIPLE INVALID CONTACTS WITH IMPEDANCES ABOVE 11,000 OHMS. THE PATIENT REPORTS NO HISTORY OF FALLS OR MAJOR ACCIDENTS. THE PATIENT REPORTS NO HISTORY OF FALLS OR MAJOR ACCIDENTS. REPROGRAMMING WAS ABLE TO ACHIEVE EFFECTIVE STIMULATION. FOLLOW UP INFORMATION IDENTIFIED XRAYS WERE TAKEN AND SHOWED A LEAD FRACTURE. THE PATIENT DENIES ANY TRAUMA THAT MAY HAVE CAUSE THE FRACTURE. SURGICAL INTERVENTION IS PENDING TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303384 LAMITRODE TRIPOLE 16 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3219 3700345

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other IMPLANT DATE:| SCS IPG: MODEL 3788