BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL STS

    MDR report key: 4880594 · Received June 30, 2015

    Report

    Report Number
    2017865-2015-07703
    Event Type
    Malfunction
    Date Received
    June 30, 2015
    Date of Event
    May 5, 2015
    Report Date
    May 5, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE LEAD REVISION, THE ATRIAL LEAD EXHIBITED A LOSS OF CAPTURE AND A LOSS OF SENSING. IT WAS NOTED THAT THE PATIENT HAD TWIDDLER'S SYNDROME. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS DOING WELL POST PROCEDURE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION NOTED THAT THE LEAD ALSO EXHIBITED DISLODGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420914 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2088TC/52 4759348

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention