BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 4

    MDR report key: 3142182 · Received May 29, 2013

    Report

    Report Number
    1627487-2013-01618
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 1, 2012
    Report Date
    May 7, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    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

    DEVICE 2 OF 2. REFERENCE MFR. REPORT: 1627487-2013-1618. IT WAS REPORTED THE PT'S ENTIRE SCS SYSTEM WAS ALLEGEDLY EXPLANTED IN (B)(6) 2012 (EXACT DATE UNK). ON (B)(6) 2012, ST. JUDE MEDICAL, NEUROMODULATION DIVISION, SENT FIELD ACTION LETTERS TO PATIENTS RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PATIENTS. AN INCREASE IN PRIOR NON-REPORTED HEATING WHILE CHARGING EVENTS AND OTHER NON-REPORTED EVENTS WAS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235269 LAMITRODE 4 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3240 2838253

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention