BEUDAMED
    FDA Adverse Event Death Summary report: N

    RIATA LEAD

    MDR report key: 18171194 · Received November 20, 2023

    Report

    Report Number
    2017865-2023-51852
    Event Type
    Death
    Date Received
    November 20, 2023
    Report Date
    November 20, 2023
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION E: JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY: TITLE: POORER OUTCOMES ASSOCIATED WITH MORE INVASIVE LEAD MANAGEMENT STRATEGIES FOR ABBOTT RIATA® LEADS: A LARGE, MULTICENTER EXPERIENCE; AUTHORS: AUTHORS (PHILIP L. MAR, CHRISTINA TSAI, LOLITA GOLEMI, ROHIL BEDI, ALI KHAN, RAJESH KABRA, DONITA ATKINS, DEEPAK BHAKTA, DHANUNJAYA LAKKIREDDY & RAKESH GOPINATHANNAIR): PUBLISHED: 26 OCTOBER 2023. NOTE: SPECIFIC SERIAL NUMBERS WERE NOT PROVIDED AND THERE IS AN INABILITY TO ATTRIBUTE THE SPECIFIC OBSERVATIONS OR ADVERSE EVENTS IN THE JOURNAL TO SPECIFIC SUBJECTS OR FOR A COMPLETE INVESTIGATION TO BE PERFORMED, AS SERIAL NUMBERS ARE NOT LISTED IN THE JOURNAL. THERE IS ALSO AN INABILITY TO VERIFY WHETHER THESE EVENTS /LEADS HAVE BEEN PREVIOUSLY REPORTED AS NO SERIAL NUMBERS OR PATIENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    A JOURNAL WAS RECEIVED WHEREBY A RETROSPECTIVE STUDY WAS PERFORMED TO ASSESS VARIOUS MANAGEMENT STRATEGIES SURROUNDING ISSUES OBSERVED WITH RECALLED ABBOTT RIATA LEADS. THE STUDY INCLUDED THE FOLLOWING MANAGEMENT STRATEGIES: (1) LEAD EXTRACTION (LE) (2) LEAD ABANDONMENT/REVISION (LA) (3) LEAD REPLACEMENT AT THE TIME OF GENERATOR CHANGE AT THE ELECTIVE REPLACEMENT INDICATOR (ERI) (GC). THE MULTICENTER STUDY LOOKED AT 152 PATIENTS FOLLOWING INTERVENTION AND NOTED THAT OUT OF 166 PROCEDURES 13 PATIENTS UNDERWENT LE, 16 UNDERWENT LA AND 137 PATIENTS UNDERWENT GC. A MAJOR COMPLICATION WAS OBSERVED IN EACH GROUP WITH SIGNIFICANT MORE SHORT TERM AND TOTAL ADVERSE OUTCOMES OBSERVED IN PATIENTS GETTING LE AND LA VERSUS GC. 3 RIATA MALFUNCTIONS WERE NOTED DURING FOLLOW UP. INAPPROPRIATE SHOCKS WERE SIMILAR AMONG THE THREE GROUPS. THE STUDY CONCLUDED MORE ADVERSE OUTCOMES IN INVASIVE MANAGEMENT STRATEGIES SUCH AS LE AND LA VERSUS GC ALONE. 13 LEAD EXTRACTIONS (LE) RESULTED IN (N=5) ¿ 2 DEATHS, 1 POCKET COMPLICATION, 2 CONGESTIVE HEART FAILURES. 16 LEAD ABANDONMENT/REVISIONS RESULTED IN (N=5) ¿ 2 LEAD REVISIONS, 1, POCKET COMPLICATION, 1 VENTRICULAR TACHYCARDIA, 1 CONGESTIVE HEART FAILURE. 137 GENERATOR CHANGES RESULTED IN (N=8) ¿ 1 STROKE, 1 LEAD MALFUNCTION, 1CHOLECYSTITIS 1 SEIZURE, 1 NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI), 1 VENTRICULAR TACHYCARDIA, 2 CHF WITH 3 LEAD MALFUNCTIONS OBSERVED OVER ~33 MONTHS OF FOLLOW UP. NOTE: THE MODELS AND NUMBER OF RIATA LEADS IN THE JOURNAL ARE LISTED BELOW BUT THE SPECIFIC INCIDENCE OR ADVERSE EVENT ATTRIBUTED TO EACH INDIVIDUAL MODEL IS UNKNOWN AS REFERENCES IN THE JOURNAL WERE NOT SPECIFIC BUT GENERALIZED. MODEL 1580 ¿ 8, MODEL 1581 ¿ 14, MODEL 7000 ¿ 4, MODEL 7001 ¿ 1, MODEL 7040 ¿ 1. IT IS NOTED IN THE REPORT THAT 2 PATIENTS IN THE LE GROUP DIED DURING INITIAL HOSPITALIZATION (SEPSIS AND GASTROINTESTINAL BLEED) WHILE THERE WERE NO DEATHS IN THE OTHER GROUPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1855085 RIATA LEAD Permanent defibrillator electrodes NVY ST. JUDE MEDICAL, INC.(CRM-SYLMAR) RIATA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death| H| L| R| O