BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERMANENT DEFIBRILLATOR ELECTRODES

    MDR report key: 24871307 · Received April 13, 2026

    Report

    Report Number
    MW5186785
    Event Type
    Other
    Date Received
    April 13, 2026
    Report Date
    January 21, 2026
    Manufacturer
    ST JUDE MEDICAL/ ABBOTT MEDICAL
    Product Code
    NVY
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED DUE TO OTHER/NON-PRODUCT EXPERIENCE AND A NON (B)(6) RIGHT VENTRICULAR LEAD WAS SURGICALLY ABANDONED DUE TO A PRODUCT PERFORMANCE ISSUE. NO PRODUCT PERFORMANCE ALLEGATIONS HAVE BEEN REPORTED. A NEW CRT-D WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D HAS BEEN RETURNED FOR ANALYSIS. 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
    928659 PERMANENT DEFIBRILLATOR ELECTRODES PERMANENT DEFIBRILLATOR ELECTRODES NVY ST JUDE MEDICAL/ ABBOTT MEDICAL 7121Q

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown