BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16C

    MDR report key: 3052367 · Received April 3, 2013

    Report

    Report Number
    1627487-2013-06138
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 12, 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
    NV, 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 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-06139. IT WAS REPORTED THE PATIENT IS PLANNING TO HAVE THE SCS SYSTEM EXPLANTED. THE PATIENT REPORTED RELIEF FROM THE STIMULATION HAS DECREASE AND THE STIMULATION IS INTOLERABLE AT NIGHT OR WHEN LYING ON HIS BACK. ALSO, THE LACK OF RELIEF CAUSES HIM TO TURN UP THE AMPLITUDE HIGHER, RESULTING IN FREQUENT CHARGING. THE PATIENT PLANS TO CONTACT HIS PHYSICIAN TO HAVE THE SYSTEM SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137436 LAMITRODE TRIPOLE 16C SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3214 2754417

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention