BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELUTE

    MDR report key: 2913370 · Received January 14, 2013

    Report

    Report Number
    2124215-2012-17095
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    November 30, 2012
    Report Date
    December 14, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 VIA ANOTHER MANUFACTURE'S SALES REPRESENTATIVE, THAT THIS CHRONIC RIGHT VENTRICULAR (RV) LEAD DISPLAYED LOSS OF VENTRICULAR CAPTURE THROUGH A HOLTER MONITOR. DURING THE OBSERVED EPISODES, THE PATIENT REPORTED TO HAVE BEEN PRE-SYNCOPAL. THE PATIENT WAS SEEN IN CLINIC FOR ADDITIONAL TESTING WHERE THRESHOLD AND IMPEDANCE MEASUREMENTS WERE STABLE. LOSS OF CAPTURE WAS NOT ABLE TO BE REPRODUCED THROUGH ISOMETRICS AND POCKET MANIPULATION. THE DEVICE SENSITIVITY WAS REPORTED TO HAVE BEEN REPROGRAMMED. OF NOTE, THE PATIENT'S DEVICE HAD RECENTLY BEEN CHANGED OUT. DURING THAT PROCEDURE, THE PHYSICIAN NOTED THAT THERE WAS A LOT OF SCAR TISSUE WITHIN THE SYSTEM AROUND THE LEADS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. AVAILABLE INFORMATION INDICATES THAT THE LEAD REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20165 SELUTE IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4285

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR 4285| 4269| MISMATCH