BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIANCE 4-FRONT

    MDR report key: 18271662 · Received December 5, 2023

    Report

    Report Number
    2124215-2023-68997
    Event Type
    Injury
    Date Received
    December 5, 2023
    Date of Event
    March 4, 2021
    Report Date
    December 5, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    PMA / PMN Number
    P910073/S145
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE HAS BEEN EXHIBITING INCREASING HIGH, OUT OF RANGE SHOCK IMPEDANCE FOR THE LAST COUPLE OF YEARS. THE MOST RECENT SHOCK IMPEDANCE WAS GREATER THAN 142 OHMS. THE PHYSICIAN CONTACTED TECHNICAL SERVICE (TS) FOR RECOMMENDATIONS. TS PROVIDED RECOMMENDATIONS FOR LEAD INTEGRITY TESTING, PATIENT MANEUVERS/ISOMETRICS, POCKET MANIPULATION, SYNC SHOCKS AND X-RAY IMAGING. THE DEVICE REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NEW INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT WAS SEEN IN THE OFFICE FOR A FOLLOW UP APPOINTMENT. THE MOST RECENT HIGH, OUT OF RANGE SHOCK IMPEDANCE WAS 150 OHMS. PHYSICIAN PERFORMED LEAD INTEGRITY TESTING, WITH POCKET MANEUVERS, WHICH DID NOT REVEAL ANY LEAD IMPAIRMENT. A COMMANDED SYNC SHOCK @ 1.1J YIELDED SHOCK IMPEDANCE OF 104 OHMS, AND AN ADDITIONAL COMMANDED SYNC SHOCK WAS PERFORMED @ 41J. THIS SHOCK GAVE A CODE 1005, INDICATIVE OF A SHORT OPEN CIRCUIT. A TECHNICAL SERVICE (TS) CONSULTANT REVIEWED DEVICE DATA, CONFIRMED THE CODE 1005 AND PROVIDED RECOMMENDATIONS FOR A SYSTEM REPLACEMENT. THIS PATIENT WILL BE SCHEDULED FOR SURGICAL INTERVENTION IN THE NEAR FUTURE. AT THIS TIME THE DEVICE AND LEAD REMAIN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2159242 RELIANCE 4-FRONT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION 0692 521704

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown