BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENOUS

    MDR report key: 2780146 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12476
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 1, 2011
    Report Date
    September 10, 2012
    Manufacturer
    HISTORICAL CPI ST. PAUL
    Product Code
    NVN
    PMA / PMN Number
    K893957
    Adverse Event
    Yes
    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 THE PATIENT WITH THIS DEVICE SYSTEM WAS LOST TO FOLLOW UP. UPON RECENT DEVICE INTERROGATION, THE DEVICE HAD DECLARED END OF LIFE (EOL). ADDITIONALLY, THIS RIGHT ATRIAL (RA) LEAD PACING IMPEDANCE MEASUREMENTS HAD BEEN LESS THAN 100 OHMS FOR APPROXIMATELY ONE YEAR. A REVISION PROCEDURE WAS PERFORMED AND THE RA LEAD WAS SURGICALLY ABANDONED AND THE DEVICE WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSVENOUS IMPLANTABLE LEAD NVN HISTORICAL CPI ST. PAUL 4271

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| L| R 4285| 1297| 4271| 1230