BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 5321417 · Received December 22, 2015

    Report

    Report Number
    3010215456-2015-33046
    Event Type
    Injury
    Date Received
    December 22, 2015
    Report Date
    November 12, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC. (CRM-KISTA)
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FOLLOWING DAY AFTER THE A NEW PULSE GENERATOR WAS IMPLANTED, THE ATRIAL LEAD EXHIBITED A DROP IN SENSING AND FARFIELD R WAVE WHICH CAUSED INAPPROPRIATE MODE SWITCHES. THE PATIENT WAS NOTED TO HAVE PAROXYSMAL ATRIAL FIBRILLATION (PAF) AND IT MADE IT DIFFICULT TO DISTINGUISH INAPPROPRIATE MODE SWITCHES. THE PATIENT NOTED EXPERIENCING OCCASIONAL PALPITATIONS BUT IT WAS DIFFICULT TO DETERMINE IF PAF CONTRIBUTED TO THE SYMPTOMS. THE PHYSICIAN ELECTED TO CAP AND REPLACE THE LEAD. THE PATIENT WAS IN STABLE CONDITION POST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843546 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC. (CRM-KISTA) 2088TC/52 4411312

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention