BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTISENSE

    MDR report key: 1896562 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05039
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 1, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    A FOLLOW-UP CORONARY ANGIOGRAM WAS CONDUCTED 6-9 MONTHS POST PROCEDURE AND A STENT FRACTURE/SEPARATION (POPMA IV) WAS OBSERVED, HOWEVER, NO BINARY RESTENOSIS WAS OBSERVED AT THE FRACTURE SITE. THE DIAMETER OF STENOSIS WAS 49%. THIS COMPLAINT WAS RECEIVED VIA LITERATURE FROM AMERICAN HEART JOURNAL 2010;160:775.E1-775.E9, "SERIAL ANGIOGRAPHIC FINDINGS AND PROGNOSIS OF STENT FRACTURE SITE WITHOUT EARLY RESTENOSIS AFTER SIROLIMUS-ELUTING STENT IMPLANTATION". THE PATIENT WAS ADMITTED FOR A PROCEDURE WITH STABLE CORONARY ARTERY DISEASE. THE PATIENT HAD A LESION IN THE RIGHT CORONARY ARTERY, HOWEVER, THE DETAILS OF THE LESION WERE NOT SPECIFIED. THE DIAMETER OF THE VESSEL AND THE LESION LENGTH WERE UNKNOWN. THE PATIENT HAD THREE CYPHER STENTS IMPLANTED. THE DATE OF THE PROCEDURE AND THE DETAILS OF THE STENT IMPLANTATION WERE UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED POOR SENSING AND CAPTURE THRESHOLDS. THE LEAD WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTISENSE PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1699TC/46

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention