BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIANCE 4-FRONT

    MDR report key: 15365716 · Received September 6, 2022

    Report

    Report Number
    2124215-2022-34456
    Event Type
    Injury
    Date Received
    September 6, 2022
    Date of Event
    September 1, 2022
    Report Date
    September 6, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526496967
    PMA / PMN Number
    P910073/S145
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT UNDERWENT A PLANNED SYSTEM REPLACEMENT PROCEDURE TO UPGRADE THERAPY FROM A PACEMAKER SYSTEM TO AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. AFTER THE PROCEDURE, THE PATIENT WAS TRANSFERRED OUT OF THE SURGICAL SUITE AND PUT ON A MONITOR. THE NURSES MONITORING THE PATIENT CONTACTED THE BOSTON SCIENTIFIC FIELD REPRESENTATIVE WHO ATTENDED THE SURGICAL PROCEDURE APPROXIMATELY ONE HOUR LATER INDICATING THE PATIENT WAS EXHIBITING PAUSES IN RHYTHM AND SOME ASYSTOLE AS OBSERVED ON THE MONITOR. THE PATIENT WAS NOTED TO BE PACE THERAPY DEPENDENT. THE PATIENT ALSO DESCRIBED A SENSATION OF WHAT FELT LIKE ELECTRICITY RUNNING DOWN THEIR ARM. THE PATIENT WAS PROVIDED EXTERNAL PACING THERAPY AND A CHEST TUBE WAS PLACED DUE TO PNEUMOTHORAX. WHEN THE REPRESENTATIVE ARRIVED BACK AT THE HOSPITAL, THIS NEWLY IMPLANTED RIGHT VENTRICULAR (RV) LEAD WAS REPROGRAMMED TO MAXIMUM PACING OUTPUT AND CONSISTENT CAPTURE WAS OBSERVED. THE PHYSICIAN ELECTED TO REPOSITION THE NEW RV LEAD AND CONNECTED A PACING SYSTEM ANALYZER (PSA) TO THE PREVIOUS RV LEAD THAT HAD BEEN SURGICALLY ABANDONED IN ORDER TO PROVIDE PACING THERAPY DURING THE SURGICAL PROCEDURE. THE NEW RV LEAD WAS SURGICALLY REPOSITIONED TO A SLIGHTLY DIFFERENT LOCATION IN THE RIGHT VENTRICLE AND WAS INDICATING TO BE PERFORMING WELL. THE RV LEAD REMAINS IN-SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2831281 RELIANCE 4-FRONT IMPLANTABLE LEAD LWS BOSTON SCIENTIFIC CORPORATION 0665 505012 00802526496967

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Male Hospitalization| R