BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROPONENT MRI DR

    MDR report key: 16645173 · Received March 30, 2023

    Report

    Report Number
    2124215-2023-14970
    Event Type
    Injury
    Date Received
    March 30, 2023
    Date of Event
    February 18, 2022
    Report Date
    April 11, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    PMA / PMN Number
    P150012/S000
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED. PLEASE REFER TO B5 DESCRIBE EVENT OR PROBLEM FOR MORE INFORMATION REGARDING THE SPECIFIC CIRCUMSTANCES OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PACEMAKER WAS PACING AT 50 BEATS PER MINUTE (BPM) IN THE MOST RECENT ATRIAL TACHY RESPONSE (ATR) EPISODES IN 2022 AND PROGRAMMING WAS SET TO DDD. THE PATIENT EXPERIENCED SYNCOPE BUT IT WAS NOT DETAILED WHETHER THE SYNCOPE OCCURRED IN 2022 OR RECENTLY. HOWEVER, THE SYNCOPE WAS REPORTED AS AN OUTCOME OF LOWER RATE LIMIT (LRL). THERE WAS A FOLLOW UP ON 03MAR2022 WHICH THE DEVICE SETTINGS WERE MODIFIED TO VVIR 70BPM AS LRL. IT WAS RECOMMENDED AS DESCRIBED IN THE USER'S MANUAL TO RESET COUNTERS AT EACH FOLLOW-UP, WHICH DID NOT HAPPEN AS LATITUDE STILL HAS THE EPISODES FROM 2022 AS THE LAST TIME THE COUNTER WERE RESET IN 20SEP2021. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN-SERVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PACEMAKER WAS PACING AT 50 BEATS PER MINUTE (BPM) IN THE MOST RECENT ATRIAL TACHY RESPONSE (ATR) EPISODES IN 2022 AND PROGRAMMING WAS SET TO DDD. THE PATIENT EXPERIENCED SYNCOPE BUT IT WAS NOT DETAILED WHETHER THE SYNCOPE OCCURRED IN 2022 OR RECENTLY. HOWEVER, THE SYNCOPE WAS REPORTED AS A OUTCOMES OF LOWER RATE LIMIT (LRL). THERE WAS A FOLLOW UP ON (B)(6) 2022 WHICH THE DEVICE SETTINGS WERE MODIFIED TO VVIR 70BPM AS LRL. IT WAS RECOMMENDED AS DESCRIBED IN THE USER'S MANUAL TO RESET COUNTERS AT EACH FOLLOW-UP, WHICH DID NOT HAPPEN AS LATITUDE STILL HAS THE EPISODES FROM 2022 AS THE LAST TIME THE COUNTER WERE RESET IN (B)(6) 2021. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN-SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566425 PROPONENT MRI DR IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION L211 564245

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other