BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 4252874 · Received November 11, 2014

    Report

    Report Number
    1627487-2014-20417
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    June 25, 2013
    Report Date
    October 22, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UDI (DI): (B)(4). 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 EXPERIENCED LOSS OF STIMULATION. SJM REPRESENTATIVE WAS ABLE TO RESOLVE THE ISSUE BY REPROGRAMMING AT THE TIME. HOWEVER, ISSUE RECURRED AND PROGRAMMING WAS TRIED TO NO AVAIL. THE PATIENT EXPERIENCED SEVERAL FALLS IN THE PAST. X-RAYS REVEALED FRACTURE ON THE LEAD. SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726452 LAMITRODE TRIPOLE 16 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3219 3376667

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other IMPLANT DATE:| SCS IPG: MODEL 3788