BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 3850254 · Received May 15, 2014

    Report

    Report Number
    1627487-2014-01307
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    November 1, 2013
    Report Date
    April 21, 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 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 IS NOT RECEIVING EFFECTIVE STIMULATION AND DOES NOT HAVE LEFT-SIDED COVERAGE. THE PT WAS IMPLANTED FOR BILATERAL COVERAGE BUT HAS RIGHT- SIDED PAIN COVERAGE. FOLLOW-UP REVEALED SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2014 AND A NEW LEAD WAS ADDED AT THE T10-11 LEVEL. EFFECTIVE STIMULATION WAS ACHIEVED POSTOPERATIVELY AND THE ISSUE IS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291446 LAMITRODE TRIPOLE 16 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3219 3538801

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other IMPLANT DATE:| SCS IPG: MODEL 3788