BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY MRI

    MDR report key: 11039547 · Received December 18, 2020

    Report

    Report Number
    2124215-2020-25026
    Event Type
    Injury
    Date Received
    December 18, 2020
    Date of Event
    October 2, 2020
    Report Date
    June 24, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVN
    UDI-DI
    00802526523335
    PMA / PMN Number
    P150012/S000
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECEIVED A CALL FROM THE FIELD REPRESENTATIVE ABOUT LOSS OF CAPTURE (LOC) ON THE TELEMETRY STRIPS HOURS AFTER THE DEVICE AND LEADS WERE IMPLANTED. TS REVIEWED THE ELECTROGRAM ON LATITUDE AND SAW NO ISSUES, BUT SAW ON THE TELEMETRY STRIPS THERE WAS POSSIBLE LOC OR FUSION BEATS WITH POTENTIALLY GREATER THAN TWO SECONDS OF ASYSTOLE. THE FIELD REPRESENTATIVE NOTED THAT THEY SAW NO ISSUES DURING THE POWER-ON SELF TEST (POST) AND THE DEVICE CHECKED OUT PERFECTLY. THE DEVICE AND RIGHT VENTRICULAR LEAD WERE LATER REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECEIVED A CALL FROM THE FIELD REPRESENTATIVE ABOUT LOSS OF CAPTURE (LOC) ON THE TELEMETRY STRIPS HOURS AFTER THE DEVICE AND LEADS WERE IMPLANTED. TS REVIEWED THE ELECTROGRAM ON LATITUDE AND SAW NO ISSUES, BUT SAW ON THE TELEMETRY STRIPS THERE WAS POSSIBLE LOC OR FUSION BEATS WITH POTENTIALLY GREATER THAN TWO SECONDS OF ASYSTOLE. THE FIELD REPRESENTATIVE NOTED THAT THEY SAW NO ISSUES DURING THE POWER-ON SELF TEST (POST) AND THE DEVICE CHECKED OUT PERFECTLY. THE DEVICE AND LEADS REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1502960 INGEVITY MRI IMPLANTABLE LEAD NVN BOSTON SCIENTIFIC CORPORATION 7732 1015242 00802526523335

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R