BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 3850731 · Received May 21, 2014

    Report

    Report Number
    1627487-2014-05363
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 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 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

    ON (B)(6) 2014, THE DOCTOR DECIDED TO ELECTIVELY EXPLANT AND REPLACE THE PATIENT'S ORIGINAL LEAD. DURING THE PROCEDURE, THE DOCTOR WAS UNABLE TO PLACE THE REPLACEMENT LEAD DUE TO SCAR TISSUE AND SPINAL STENOSIS. THE PROCEDURE WAS ABANDONED AFTER MULTIPLE ATTEMPTS. THE DOCTOR ALSO ELECTIVELY EXPLANTED THE PATIENT'S IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303597 LAMITRODE TRIPOLE 16 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3219 4103504

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other