BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 5241989 · Received November 22, 2015

    Report

    Report Number
    2017865-2015-30418
    Event Type
    Injury
    Date Received
    November 22, 2015
    Date of Event
    October 15, 2015
    Report Date
    October 15, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A ROUTINE FOLLOW-UP EXPERIENCING SHORTNESS OF BREATH. UPON INTERROGATION, THE RIGHT VENTRICULAR LEAD EXHIBITED LOSS OF CAPTURE AND SENSING; IMAGING REVEALED THE LEAD HAD DISLODGED. THE PHYSICIAN ELECTED TO CAP AND REPLACE THE LEAD. THE PATIENT TOLERATED THE PROCEDURE WELL AND WOULD CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772120 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1888TC/58 0002132947

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention