BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSVENOUS

    MDR report key: 1953783 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24155
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 8, 2010
    Manufacturer
    HISTORICAL CPI ST. PAUL
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN AT THIS TIME IF THE LEAD WILL BE RETURNED FOR ANALYSIS. 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 DURING A REPLACEMENT PROCEDURE, THE TERMINAL PIN FOR THIS RIGHT VENTRICULAR (RV) LEAD SEPARATED FROM THE LEAD BODY WHEN IT WAS PULLED OUT OF THE DEVICE HEADER. THE LEAD EXHIBITED INSULATION DAMAGE AND WAS NOT CAPABLE OF MEASURING IMPEDANCE. THIS LEAD WAS SUCCESSFULLY REPLACED. NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSVENOUS IMPLANTABLE LEAD NVN HISTORICAL CPI ST. PAUL 4261

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR (B)(4)| MISMATCH| (B)(4)| (B)(4)| (B)(4)