BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 2903340 · Received December 14, 2012

    Report

    Report Number
    1627487-2012-06935
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 24, 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 INFORMATION 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

    ON (B)(6) 2012, THE PT UNDERWENT A PERMANENT IMPLANT PROCEDURE. DURING THE PROCEDURE, THE DOCTOR WAS UNABLE TO IMPLANT THE LEAD IN THE DESIRED LOCATION. THE PT HAS BEEN RECEIVING INADEQUATE SINCE BEING IMPLANTED. REPROGRAMMING ATTEMPTS HAVE BEEN UNSUCCESSFUL. AN SJM REP PLANS TO CONTINUE TROUBLESHOOTING THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE 16 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3219 3736395

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention SCS IPG: MODEL 3688| IMPLANT: