BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIOPOLE 16

    MDR report key: 3010526 · Received March 14, 2013

    Report

    Report Number
    1627487-2013-01283
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    February 21, 2012
    Report Date
    February 21, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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

    DEVICE 2 OF 2. REFERENCE MFR REPORT # 1627487-2013-1282. IT WAS REPORTED THE PT'S IPG STOPPED COMMUNICATING ABOUT A YEAR AGO. AN SJM REP MET WITH THE PT AND CONFIRMED THE ISSUE. IT WAS ALSO REPORTED THE PT WASN'T RECEIVING EFFECTIVE STIMULATION WHEN HER IPG WAS WORKING. THE PT IS CONSIDERING HAVING HER IPG REPLACED WITH NEW ONE. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108279 LAMITRODE TRIOPOLE 16 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3219 2847763

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention