BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENOUS

    MDR report key: 1953649 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24072
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 10, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT IMPEDANCES WERE < 200 OHMS ON THIS ATRIAL LEAD AND THERE WAS SUSPECT OF A LEAD FRACTURE. A LEAD REVISION WAS PERFORMED. HOWEVER THE PHYSICIAN DID NOT WISH TO PLUG THE ATRIAL PORT OF THE NEW DEVICE AND THEREFORE THIS CHRONIC LEAD WAS PLUGGED INTO THE NEW CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). TECHNICAL SERVICES DISCUSSED PROGRAMMING OPTIONS REVOLVING AROUND THIS LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSVENOUS IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4271

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention 0125| H135| 4271| 1810| 4513| H179