BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRENT DR FGI

    MDR report key: 8295238 · Received January 31, 2019

    Report

    Report Number
    2017865-2019-01528
    Event Type
    Malfunction
    Date Received
    January 31, 2019
    Date of Event
    May 19, 2008
    Report Date
    January 31, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A SYSTEM IMPLANT PROCEDURE. DURING IMPLANTABLE CARDIOVERTER DEFIBRILLATOR PLACEMENT, AN UNSPECIFIED SETSCREW ANOMALY WAS OBSERVED. THE DEVICE WAS REMOVED AND REPLACED. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED DECREASED HIGH VOLTAGE LEAD IMPEDANCE. THE LEAD WAS REPLACED ON AN UNKNOWN DATE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85473 CURRENT DR FGI IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD2207-36

    Patients

    Seq Age Sex Outcome Treatment
    1