BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY MRI

    MDR report key: 15978525 · Received December 14, 2022

    Report

    Report Number
    2124215-2022-52650
    Event Type
    Injury
    Date Received
    December 14, 2022
    Date of Event
    November 2, 2022
    Report Date
    February 9, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVN
    PMA / PMN Number
    P150012/S000
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED LEAD WAS ANALYZED. RESISTANCE TESTING CONFIRMED THE LEAD WAS NOT ELECTRICALLY CONTIGUOUS. MICROSCOPIC EVALUATION INDICATED THAT THE THERE WAS A FRACTURED ANODE COIL APPROXIMATELY ~233-240 MM NEAR THE TERMINAL PIN. DUE TO THE LOCATION AND THE TYPE OF DAMAGE EXHIBITED, IT WAS CONCLUDED THAT THE DAMAGE WAS CAUSED BY LEAD ENTRAPMENT IN THE CLAVICLE/FIRST-RIB REGION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNSPECIFIED INCREASED IMPEDANCE MEASUREMENTS. DIAGNOSTIC IMAGING WAS PERFORMED WHICH CONFIRMED THE RV LEAD WAS DAMAGED. THE PHYSICIAN SUBSEQUENTLY SURGICALLY EXPLANTED AND REPLACED THE RV LEAD TO RESOLVE THE EVENT. THE PATIENT WAS STABLE WITH NO ADDITIONAL ADVERSE EFFECTS. THE RV LEAD IS EXPECTED TO BE RETURNED FOR ANALYSIS, BUT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNSPECIFIED INCREASED IMPEDANCE MEASUREMENTS. DIAGNOSTIC IMAGING WAS PERFORMED WHICH CONFIRMED THE RV LEAD WAS DAMAGED. THE PHYSICIAN SUBSEQUENTLY SURGICALLY EXPLANTED AND REPLACED THE RV LEAD TO RESOLVE THE EVENT. THE PATIENT WAS STABLE WITH NO ADDITIONAL ADVERSE EFFECTS. THE RV LEAD WAS RECEIVED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2141783 INGEVITY MRI DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES NVN BOSTON SCIENTIFIC CORPORATION 7742 1118639

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Unknown Required Intervention| H