BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK C

    MDR report key: 1771484 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12670
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 10, 2010
    Report Date
    June 9, 2010
    Manufacturer
    HISTORICAL CPI ST. PAUL
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO A FRACTURE. IT WAS NOTED THAT THERE WERE SEVERAL EPISODES OF NOISE ON THE RV LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATED THAT A LEAD FRACTURE WAS NOT CONFIRMED; HOWEVER, IT WAS SUSPECTED TO BE A LEAD FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK C IMPLANTABLE LEAD NVY HISTORICAL CPI ST. PAUL 0074

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR 1705| 0074| H177| 6931| 6024| 1746| 0186| 4525| 4543| 4470| 4592| N119