BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16C

    MDR report key: 3223233 · Received July 10, 2013

    Report

    Report Number
    1627487-2013-06596
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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

    IT WAS REPORTED THE PATIENT WAS NOT RECEIVING EFFECTIVE STIMULATION. THE SCS LEAD WAS NOT IN THE PROPER LOCATION TO PROVIDE COVERAGE OF THE PATIENT'S PAIN PATTERN. THE LEAD WAS REPLACED WITH A NEW ONE. ADDITIONALLY, DURING THE PROCEDURE THE PHYSICIAN DECIDED TO ELECTIVELY REPLACE THE PATIENT'S SCS IPG. THERE WAS NO KNOWN ALLEGED DEFICIENCY WITH THE IPG. THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314904 LAMITRODE TRIPOLE 16C SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3214 68939

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other SCS IPG: MODEL 3716| IMPLANT DATE: