BEUDAMED
    FDA Adverse Event Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 1895631 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04424
    Date Received
    November 10, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS FOUND THE LEAD FRACTURED 33.5CM FROM THE CONNECTOR. THE IS-1 DISTAL COIL, DF-1 RV AND DF-1 SVC CABLES WERE FRACTURED IN THE SAME AREA. IT IS BELIEVED THAT THE FRACTURES WERE CAUSED BY CLAVICLE CRUSH.

    Additional Manufacturer Narrative · 1

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

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED A SHOCK. THE RV CAPTURE THRESHOLD HAD INCREASED. A FRACTURE WAS NOTED ON THE LEAD. THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7001/65

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)