BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 3052901 · Received April 2, 2013

    Report

    Report Number
    1627487-2013-04396
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 2, 2013
    Report Date
    March 11, 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

    THE PT REPORTED, SHE HAD A MINI STROKE. IT WAS REPORTED, THE PT HAD BEEN IN PAIN, BUT THE PAIN HAD SUBSIDED SOME FROM THE INITIAL INCIDENT. THE PT REPORTS, SHE WAS HAVING TROUBLE WITH WALKING. IN ADDITION, THE PT REPORTED, SHE WAS REPROGRAMMED A WEEK BEFORE, AND WAS NOT RECEIVING EFFECTIVE STIMULATION. THE PT REPORTED, THE STIMULATION RELIEF HAD BEEN MORE EFFECTIVE THREE MONTHS PRIOR. AN ATTEMPT TO DETERMINE THE PT STATUS WAS UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133478 LAMITRODE TRIPOLE 16 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3219 3717046

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention IMPLANT DATE:| SCS IPG, MODEL 3788