BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, SJ4 CONNECTOR

    MDR report key: 1831198 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03517
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    July 22, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS EXPLANTED DUE TO DISLODGEMENT AND CAPTURE ANOMALY.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT PRESENTED FOR THE INDEX PROCEDURE WITH A NON-ST MYOCARDIAL INFARCTION AND THAT THE TARGET VESSEL HAD A REFERENCE VESSEL DIAMETER OF 3.0MM. 2 DAYS POST INDEX PROCEDURE, THE PATIENT DEVELOPED CHEST PAIN THAT WAS NOT RELIEVED MEDICALLY. ECG SHOWED MILD ST ELEVATION IN V1 AND FOLLOW UP ECG REVEALED SIGNIFICANT ST ELEVATION IN V1-V3. SUBSEQUENT ANGIOGRAPHY REVEALED THROMBUS IN THE PREVIOUSLY PLACED STENT. THE THROMBUS EXTENDED INTO THE LEFT MAIN CORONARY ARTERY. AN ATTEMPT WAS MADE TO TREAT THE THROMBUS USING THROMBECTOMY. HOWEVER, RESIDUAL CLOT REMAINED AND THE SUBJECT WAS REFERRED FOR EMERGENT CORONARY ARTERY BYPASS X3 SURGERY INCLUDING LEFT INTERNAL MAMMARY ARTERY GRAFT TO THE LAD, REVERSE SAPHENOUS VEIN GRAFT TO THE OBTUSE MARGINAL AND RIGHT CORONARY ARTERY. THE PATIENT WAS DISCHARGED ON ASPIRIN 11 DAYS AFTER THE ONSET OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURATA STS OPTIM ACTIVE FIXATION, SJ4 CONNECTOR DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7122Q/58

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention