BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 3231523 · Received July 12, 2013

    Report

    Report Number
    1627487-2013-04892
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 20, 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 INFO 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. REF MFR REPORT: 1627487-2013-04891. IT WAS REPORTED THE PT WAS EXPERIENCING CHANGES IN STIMULATION, AND REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. THE SJM REP MET WITH THE PT AND DETERMINED THE LEAD HAD MULTIPLE CONTACTS WITH LOW IMPEDANCES. AN X-RAY WAS TAKEN WHICH DID NOT SHOW ANOMALIES. IT WAS REPORTED SURGICAL INTERVENTION WAS TO BE UNDERTAKEN TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323699 LAMITRODE TRIPOLE 16 SCS LEAD LGW ST JUDE MEDICAL - NEUROMODULATION 3219 2763212

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other