BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENOUS

    MDR report key: 3210873 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08199
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 1, 2013
    Manufacturer
    HISTORICAL CPI ST. PAUL
    Product Code
    NVN
    PMA / PMN Number
    K822485
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN HAD ELECTED TO REPROGRAM THE DEVICE TO ATRIAL-ONLY PACING (AOO); THE DEVICE AND LEADS REMAIN IN SERVICE. 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 SHORTLY AFTER THE DEVICE REPLACEMENT PROCEDURE, THIS DEVICE AND CHRONIC RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE THAT WAS OVERSENSED. A REVIEW OF THE ELECTROGRAMS CONFIRMED THE NOISE AND SHOWED PAUSES IN PACING THAT MAY HAVE RESULTED IN GREATER THAN TWO SECONDS OF ASYSTOLE. THE LEAD MEASUREMENTS WERE WITHIN NORMAL LIMITS. A TECHNICAL SERVICES CONSULTANT DISCUSSED TROUBLESHOOTING TECHNIQUES FOR ATTEMPTING TO REPRODUCE THE NOISE, AS WELL AS CONFIRMING THRESHOLD AND SENSING MEASUREMENTS. THE NOISE PATTERN WAS CONSISTENT WITH A DAMAGED SEAL PLUG OR LOOSE SETSCREW. THE FIELD REPRESENTATIVE REPORTED TROUBLESHOOTING HAD BEEN PERFORMED AND THE NOISE COULD NOT BE REPRODUCED. IT WAS ALSO NOTED THAT SOME OVERSENSING ON THE CHRONIC RIGHT ATRIAL (RA) LEAD WAS ALSO OBSERVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309208 TRANSVENOUS IMPLANTABLE LEAD NVN HISTORICAL CPI ST. PAUL 4260

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening| R 4260| S602| 4266| 0925| 0950| 0940