BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST

    MDR report key: 4160946 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19063
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 1, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Removal / Correction Number
    Z-1249-2012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS PRODUCT WAS INCLUDED IN A FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT BE DETERMINED IF THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. PRODUCT EVENT SUMMARY: THE ACTUAL PRODUCT WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND WAS ANALYZED. ANALYSIS OF THE DEVICE MEMORY WAS PERFORMED AND NO ANOMALIES WERE FOUND. EPISODE TREATED AS WAVELET DID NOT WITHHOLD THERAPY. MEDIAN V-V INTERVAL IS FASTER THAN SUPRAVENTRICULAR TACHYCARDIA (SVT) TIMEOUT. OTHER EPISODES SHOW WAVELET APPROPRIATELY WITHHOLDING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN FROM RECEIVING INAPPROPRIATE THERAPY DUE TO ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS PROGRAMMED OFF DUE TO PATIENT BEING IN HOSPICE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642313 ENTRUST DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D154VRC

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Life Threatening| R