BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 3926299 · Received June 17, 2014

    Report

    Report Number
    1627487-2014-25452
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    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 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

    IT WAS REPORTED THE PT WAS EXPERIENCING INEFFECTIVE COVERAGE DUE TO LEAD MIGRATION CONFIRMED WITH X-RAYS. AS A RESULT, THE PT'S LEAD WAS REPOSITIONED ON (B)(6) 2014. EFFECTIVE THERAPY WAS NOT RESTORED POST-OP. IT IS UNK IF ANY FURTHER INTERVENTIONS WILL BE TAKEN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355942 LAMITRODE TRIPOLE 16 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3219 4287114

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other SCS IPG: MODEL 3788| IMPLANT DATE:| SCS EXTENSIONS: MODEL 3386 (X2)| IMPLANT DATE: