BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL STS

    MDR report key: 6085764 · Received November 8, 2016

    Report

    Report Number
    2938836-2016-13896
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    September 1, 2016
    Report Date
    September 1, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI (DI): (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER IMPLANTATION, LOSS OF CAPTURE WAS NOTED IN THE BIPOLAR CONFIGURATION ON BOTH LEADS. THE POOR MEASUREMENT WAS CONFIRMED WHEN THE LEADS WERE TESTED WITH THE PSA. A LOWER OUT OF RANGE PACING LEAD IMPEDANCE MEASUREMENT WAS ALSO OBSERVED. POSSIBLE INSULATION DAMAGE WAS SUSPECTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735738 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 2088TC/52 P000032367

    Patients

    Seq Age Sex Outcome Treatment
    1 2088TC/58 (B)(4)