BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 1896048 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04558
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 21, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT PRESENTED TO THE HOSPITAL AFTER RECEIVING SEVERAL INAPPROPRIATE SHOCKS DUE TO OVERSENSING. AN INCREASE IN THRESHOLD WAS ALSO NOTED. LEAD DAMAGE WAS SUSPECTED. X-RAY SHOWED THE LEAD IN THE CORONARY SINUS. IT IS UNKNOWN IF IMPLANTED IN CS ORIGINALLY OR DISLODGED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. THE TWO DEVICES HAVE BEEN REPORTED IN MFR. REPORT # 3005099803-2010-04486 AND # 3005099803-2010-04487. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO JAGTOME RX SPHINCTEROTOME WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN FOUND THE WIRE WAS ALREADY BROKEN WHEN HE OPENED THE PACKAGES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7120Q/65

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention