BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 3032279 · Received March 29, 2013

    Report

    Report Number
    1627487-2013-01354
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 6, 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 PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT SUFFERED A HEART ATTACK SHORTLY AFTER A REVISION PROCEDURE ON (B)(6) 2013 (REFERENCE MFR REPORTS: 1627487-2013-03393 AND 03394). THE PT'S HEART ISSUES SHOWED AS THE PT WAS BEING MONITORED IN POST-OP. THE PT HAD A STENT PLACED ON (B)(6) 2013. THE PT IS DOING WELL AND IS EXPECTED TO MAKE A FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130079 LAMITRODE TRIPOLE 16 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3219 3869111

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788| SCS EXTENSION: MODEL 3383 (2)