BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SQ-RX PULSE GENERATOR

    MDR report key: 14162096 · Received April 20, 2022

    Report

    Report Number
    2124215-2022-05367
    Event Type
    Malfunction
    Date Received
    April 20, 2022
    Date of Event
    January 1, 2021
    Report Date
    April 20, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE REPORT WILL BE UPDATED AT THAT TIME.

    Description of Event or Problem · 0

    SWIERZYNSKA, EWA, ET AL. (2021). "USE OF AN EXERCISE TEST TO ENHANCE SENSING VECTOR ASSESSMENT AND PREVENT INADEQUATE SUBCUTANEOUS IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR DISCHARGES." JOURNAL OF ELECTROCARDIOLOGY 67 (2021) 73-76. HTTPS://DOI.ORG/10.1016/J.JELECTROCARD.2021.05.013. THE SOURCE LITERATURE REPORTED THAT THE PATIENT WITH A SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) REPORTED THREE SHOCKS DURING EXERCISE. THE SHOCKS WERE DETERMINED TO BE INAPPROPRIATE DUE TO ATRIAL FIBRILLATION AND FAST HEART RATE RESPONSE WITH T-WAVE OVERSENSING AND DOUBLE-TRIPLE COUNTING. THE DEVICE WAS REPROGRAMMED MULTIPLE TIMES WHICH DID NOT RESULT IN ANY IMPROVEMENT AND THE PATIENT REPORTED FURTHER INAPPROPRIATE SHOCKS IN SIMILAR CIRCUMSTANCES. AN EXERCISE TEST WAS PERFORMED WHERE IT WAS DETERMINED THAT NONE OF THE AVAILABLE VECTORS WERE FREE OF ARTIFACTS. AFTER REPROGRAMMING THE SENSING VECTOR, NO INTERVENTION OCCURRED DURING THE SUBSEQUENT ONE YEAR OF OBSERVATION. THE DEVICE MODEL AND SERIAL NUMBER WERE NOT PROVIDED. AN ATTEMPT TO OBTAIN THE INFORMATION FROM THE AUTHOR IS BEING MADE. EWA SWIERZYNSKA, 1ST DEPARTMENT OF ARRHYTHMIA, NATIONAL INSTITUTE OF CARDIOLOGY, WARSAW, POLAND

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271684 SQ-RX PULSE GENERATOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Unknown