BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 3101934 · Received May 6, 2013

    Report

    Report Number
    1627487-2013-04549
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    October 12, 2010
    Report Date
    April 15, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-04550. THE PT REPORTED SHE HAD NOT RECEIVED EFFECTIVE STIMULATION AFTER REPROGRAMMING ATTEMPTS DURING THE FIRST YEAR OF THE IMPLANT OF THE SCS SYSTEM. THE PT REPORTED THE STIMULATION BECAME INEFFECTIVE AND SHE STOPPED RECHARGING THE IPG AND USING THE SYSTEM. IT WAS REPORTED THE PT WAS BUMPING AGAINST OBJECTS AND WANTED THE SYSTEM REMOVED SINCE IT WAS NOT IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197236 LAMITRODE TRIPOLE 16 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3219 3175195

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention