BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE LEAD,

    MDR report key: 17536889 · Received August 12, 2023

    Report

    Report Number
    MW5143772
    Event Type
    Injury
    Date Received
    August 12, 2023
    Report Date
    February 2, 2021
    Manufacturer
    MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
    Product Code
    NVN
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED VENTRICULAR FIBRILATION (VF). THE RIGHT VENTRICULAR (RV) LEAD WAS NOTED WITH LEAD INTEGRITY ALERT (LIA) FOR NON-SUSTAINED VENTRICULAR TACHYCARDIA AND SHORT V-V- INTERVALS. THERE WAS VARIABLE AMPLITUDE CAUSING AN UNCLEAR SENSING OF COMBINED SIGNALS. REVIEW OF THE R-WAVE TRENDING DATA REVEALED A DECREASING R-WAVE OVER TIME, WHICH WAS MORE SENSITIVE FOR UNDERSENSING. THE PATIENT'S CONDITION DETERIORATED RESULTING IN DEATH. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941578 CAPSURE SENSE LEAD, DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 181

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown