BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL MRI

    MDR report key: 8685150 · Received June 10, 2019

    Report

    Report Number
    2938836-2019-04361
    Event Type
    Injury
    Date Received
    June 10, 2019
    Date of Event
    May 23, 2019
    Report Date
    August 5, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    DXY
    UDI-DI
    05414734504621
    PMA / PMN Number
    P140033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE REPORTED EVENT OF A SENSING ISSUE AND INADEQUATE CAPTURE WERE NOT CONFIRMED IN THE LABORATORY. THE LEAD WAS RETURNED IN ONE PIECE RETRACTED AND COVERED WITH BLOOD. X-RAY EXAMINATION AND ELECTRICAL TESTING REVEALED NO ABNORMALITIES.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBERS: 2938836-2019-04358, 2938836-2019-04362. IT WAS REPORTED THAT WHEN THE PATIENT PRESENTED AT A FOLLOW-UP IN-CLINIC, FAR-FIELD P WAVE OVERSENSING WAS OBSERVED ON THE VENTRICULAR CHANNEL. PROGRAMMING CHANGES WERE MADE AND NO ADDITIONAL EPISODES OF NOISE OVERSENSING WERE SEEN. AN X-RAY REVEALED THAT BOTH THE ATRIAL AND VENTRICULAR LEADS WERE DISLODGED DUE TO TWIDDLER'S SYNDROME CAUSING POOR SENSING AND HIGH CAPTURE THRESHOLDS ON THE LEADS. IT WAS ALSO NOTED THAT NON-SUSTAINED NOISE WAS PRESENT ON THE RIGHT VENTRICULAR LEAD. BOTH LEADS WERE EXPLANTED AND REPLACED SUCCESSFULLY. THE PATIENT WAS STABLE BEFORE, DURING AND AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477617 TENDRIL MRI PERMANENT PACEMAKER ELECTRODE DXY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) LPA1200M/52 S000066039 05414734504621

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R