BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENOUS

    MDR report key: 2050350 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03232
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 2011
    Manufacturer
    HISTORICAL CPI ST. PAUL
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD HAS NOT BEEN RETURNED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS ATRIAL LEAD FRACTURED. THE LEAD WAS EXHIBITING INCREASED IMPEDANCE MEASUREMENTS, LOSS OF CAPTURE AND OVERSENSING. THE PHYSICIAN WILL BE EXTRACTING THIS LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSVENOUS IMPLANTABLE LEAD NVN HISTORICAL CPI ST. PAUL 4011

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 283| 4011| 4010