BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-ICD SYSTEM

    MDR report key: 6672686 · Received June 28, 2017

    Report

    Report Number
    2124215-2017-11167
    Event Type
    Malfunction
    Date Received
    June 28, 2017
    Date of Event
    June 5, 2017
    Report Date
    June 5, 2017
    Manufacturer
    CAMERON HEALTH
    Product Code
    LWS
    PMA / PMN Number
    P11042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION WAS NOT SUCCESSFUL. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED. JOURNAL ARTICLE REFERENCE: MESQUITA, J., D. CAVACO, ET AL. (2017). "EFFECTIVENESS OF SUBCUTANEOUS IMPLANTABLE CARDIOVERTER-DEFIBRILLATORS AND DETERMINANTS OF INAPPROPRIATE SHOCK DELIVERY." INT J CARDIOL 232: 176-180.

    Additional Manufacturer Narrative · 1

    CORRECTION: THIS REPORT IS BEING FILED TO CORRECT THE EVENT PROBLEM AND EVALUATION CODES. (B)(4).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM A JOURNAL ARTICLE ABOUT A STUDY PERFORMED TO ASSESS THE IMPACT OF PATIENT CHARACTERISTICS AND INITIAL DETECTION ALGORITHM IN THE PREVENTION AND TREATMENT OF SUDDEN CARDIAC DEATH AND DELIVERY OF INAPPROPRIATE SHOCKS. A TOTAL OF 54 PATIENTS FROM THE HOSPITAL DE SANTA CRUZ WERE ENROLLED IN THIS STUDY AND THEY WERE ALL IMPLANTED WITH SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (S-ICDS). DURING IMPLANTATION, TWO PATIENT EXPERIENCED COMPLICATIONS: AT ONE IMPLANT, THE TELEMETRY LINK WAS LOST DURING THE PROCEDURE; AND THE SECOND IMPLANT, THE S-ICD HAD TO BE REPOSITIONED DUE TO UNSUCCESSFUL CONVERSION DURING DEFIBRILLATION TESTING (DFT). DURING THE COURSE OF THE STUDY, A TOTAL OF 9 PATIENTS RECEIVED INAPPROPRIATE SHOCKS. FIVE PATIENT RECEIVED INAPPROPRIATE SHOCKS DUE TO T-WAVE OVERSENSING, TWO PATIENTS RECEIVED SHOCKS WHILE IN ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE, ONE PATIENT RECEIVED A SHOCK DUE TO QRS COMPLEX DOUBLE COUNTING, AND ONE PATIENT RECEIVED A SHOCK WHILE IN SUPRAVENTRICULAR TACHYCARDIA (SVT). ONE OF THE PATIENT'S THAT RECEIVED INAPPROPRIATE THERAPY DUE TO T-WAVE OVERSENSING RECEIVED FIVE SHOCKS, INDICATING THERAPY EXHAUSTION IN THAT EPISODE. NO SERIAL NUMBER INFORMATION FOR ANY OF THE DEVICES IN THE LISTED PATIENTS WAS PROVIDED IN THE ARTICLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454797 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CAMERON HEALTH 1010

    Patients

    Seq Age Sex Outcome Treatment
    1 3010