BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIRM

    MDR report key: 2040728 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01134
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 9, 2011
    Report Date
    January 9, 2011
    Manufacturer
    HISTORICAL CPI ST. PAUL
    Product Code
    NVN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 FROM AN IMPLANT FORM THAT THIS PATIENT WAS PRESENTED TO THE ELECTROPHYSIOLOGY LABORATORY FOR A SCHEDULED ELECTIVE DEVICE REPLACEMENT AND RIGHT VENTRICULAR (RV) LEAD REVISION PROCEDURE. THE RV LEAD HAD BEEN EXHIBITING HIGH PACING IMPEDANCE AND HIGH PACING THRESHOLDS. THE RV LEAD WAS SURGICALLY CAPPED. SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE LOCAL REPRESENTATIVE THAT THE RV PACING IMPEDANCE MEASUREMENTS WERE GREATER THAN 2500 OHMS. HOWEVER, THERE WERE NO REPORTS OF LOSS OF CAPTURE AT MAXIMUM OUTPUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRM IMPLANTABLE LEAD NVN HISTORICAL CPI ST. PAUL 4113

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Hospitalization| L| R 1135| 1175| 4136| 0505| S601| 4113