BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 2915062 · Received December 20, 2012

    Report

    Report Number
    1627487-2012-13254
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    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

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2012-13253. BOTH LEADS ARE BEING REPORTED SINCE IT IS UNDETERMINED WHICH LEAD IS RELATED TO THIS EVENT. IT WAS REPORTED THE PHYSICIAN PLACED A LEAD DURING A PROCEDURE AND THE LEAD SHOWED INVALID CONTACTS DURING INTRAOPERATIVE TESTING. THE PHYSICIAN OPTED TO REPLACE THE LEAD. THE SECOND LEAD WAS PLACED AND ALSO SHOWED INVALID CONTACTS. IT WAS REPORTED THE PT WAS PROGRAMMED AND RECEIVED EFFECTIVE STIMULATION AND COVERAGE POST OPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE 16 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3219 3817022

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788