BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 2871456 · Received December 5, 2012

    Report

    Report Number
    1627487-2012-15009
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    October 25, 2012
    Report Date
    June 7, 2016
    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
    Health Professional
    N

    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 HAD STIMULATION IN HIS STOMACH AND WAS NO LONGER RECEIVING STIMULATION WHERE NEEDED. X-RAYS WERE TAKEN AND DID NOT REVEAL ANY ANOMALIES. FOLLOW UP INDICATED SURGICAL INTERVENTION MAY BE TAKEN AT A LATER DATE TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE 16 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3219 3577060

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788| SCS IPG: MODEL 3788| IMPLANT DATE: