BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ASSURA VR ICD, US

    MDR report key: 9130185 · Received September 27, 2019

    Report

    Report Number
    2938836-2019-14111
    Event Type
    Injury
    Date Received
    September 27, 2019
    Date of Event
    September 17, 2019
    Report Date
    July 10, 2020
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    LWS
    UDI-DI
    05414734507974
    PMA / PMN Number
    P910023
    Removal / Correction Number
    Z-0115-2017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D10, H7, H9. THE REPORTED FIELD EVENT OF A BATTERY PERFORMANCE ALERT (BPA) WAS CONFIRMED VIA REVIEW OF DEVICE IMAGE. THE ALERT WAS DUE TO A TRANSIENT DROP IN THE BATTERY VOLTAGE THAT IS CONSISTENT WITH BATTERY DEPLETION ASSOCIATED WITH LITHIUM CLUSTERS. HOWEVER, SINCE THE MONTHLY BATTERY VOLTAGE TREND AND THE OVERALL EXPECTED LONGEVITY OF THE DEVICE WAS NORMAL, PREMATURE BATTERY DEPLETION COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: AWARENESS DATE IN 2938836-2019-14111-2 SHOULD HAVE BEEN 15 NOV 2019 INSTEAD OF 15 OCT 2019.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS INCLUDED IN THE BATTERY PERFORMANCE ALERT ADVISORY ISSUED BY ABBOTT ON 28 AUGUST 2017.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT THE DEVICE ALSO EXHIBITED PREMATURE BATTERY DEPLETION.

    Description of Event or Problem · 1

    FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN AND THE DEVICE WAS EXPLANTED. THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925125 FORTIFY ASSURA VR ICD, US IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD1357-40Q 4519266 05414734507974

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention