BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 3141791 · Received May 28, 2013

    Report

    Report Number
    1627487-2013-12730
    Event Type
    Injury
    Date Received
    May 28, 2013
    Date of Event
    March 15, 2013
    Report Date
    May 2, 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
    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

    IT WAS REPORTED THE PT EXPERIENCED OCCASIONAL SHOCKING SENSATIONS IN HER RIGHT LOWER BACK ON (B)(6) 2013. THE SJM REP MET WITH THE PT TO INVESTIGATE ON (B)(6) 2013, BUT THE IPG WAS UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. THE IPG WAS EXPLANTED AND REPLACED. THE PT'S SYSTEM HAS NOT BEEN PROGRAMMED POST-SURGICALLY. NOTE: THE IPG EXPLANT AND REPLACEMENT WAS REPORTED IN MFR REPORT #1627487-2013-03627.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233205 LAMITRODE TRIPOLE 16 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3219 3255105

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention