BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 21843815 · Received April 15, 2025

    Report

    Report Number
    2017865-2025-40197
    Event Type
    Injury
    Date Received
    April 15, 2025
    Report Date
    April 15, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS ARE LISTED IN THE ARTICLE TITLED "PACING BEYOND BOUNDARIES: REPORT OF A SUCCESSFUL LEFT BUNDLE BRANCH AREA PACING IN A PATIENT WITH DEXTROCARDIA. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, SUPPL. SUPPLEMENT 85.12: 4207. HTTP://DX.DOI.ORG/10.1016/S0735-1097(25)04691-1.¿ AUTHOR: SALIH, RAYAN; DODOO, SHERIFF; AHMED, SANA; UMANA, IDOPISE; CHANDRA, SHALABH. NORTHEAST GEORGIA MEDICAL CENTER, GAINESVILLE, GA, GEORGIA HEART INSTITUTE, GAINESVILLE, GA PUBLICATION INFO: JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, SUPPL. SUPPLEMENT 85.12: 4207. ELSEVIER INC. (APR 1, 2025). NOTE: THE REPORT WAS DERIVED FROM A JOURNAL. PATIENT INFORMATION AND SPECIFIC PRODUCT DETAILS WERE NOT PROVIDED IN THE ARTICLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY THAT A TENDRIL RIGHT VENTRICULAR (RV) LEAD WAS RELATED TO A CARDIAC PERFORATION. IT WAS REPORTED THAT THE RV LEAD WAS SUCCESSFULLY IMPLANTED IN THE RV INTERVENTRICULAR SEPTUM ACHIEVING LEFT BUNDLE BRANCH AREA PACING (LBBAP) THAT WAS CONFIRMED WITH AN ELECTROCARDIOGRAM (EKG). A FOLLOW-UP TRANSTHORACIC ECHOCARDIOGRAM WAS CONCERNING FOR RV SEPTAL PERFORATION. A CARDIAC COMPUTED TOMOGRAPHY REVEALED A POSSIBLE PROTRUSION OF THE DISTAL ACTIVE-FIXATION HELIX IN THE LEFT VENTRICULAR CAVITY. A DECISION WAS MADE TO REVISE THE RV LEAD. A REPLACEMENT LBBAP LEAD WAS IMPLANTED. ADEQUATE PLACEMENT WAS CONFIRMED WITH FLUOROSCOPY AND EKG. THREE MONTHS POST-IMPLANT, THE PATIENT CONTINUED TO HAVE EXCELLENT LEAD NUMBERS AND EVIDENCE OF THE LEFT BUNDLE BRANCH CAPTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114572 TENDRIL STS No Match NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2088

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Unknown Required Intervention