BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 8149230 · Received December 10, 2018

    Report

    Report Number
    2017865-2018-18640
    Event Type
    Injury
    Date Received
    December 10, 2018
    Date of Event
    October 31, 2018
    Report Date
    December 18, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    UDI-DI
    05414734501750
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    CORRECTION: THE PREVIOUSLY REPORTED EVENT DESCRIPTION INCORRECTLY NOTED THAT THE ATRIAL LEAD WAS EXTRACTED; HOWEVER, THE RIGHT VENTRICULAR LEAD WAS EXTRACTED. CORRECTION: THE PREVIOUSLY REPORTED MODEL NUMBER, SERIAL NUMBER, LOT NUMBER, EXPIRATION DATE, UDI WERE INCORRECT. THE CORRECT MODEL NUMBER IS 1888TC/58, SERIAL NUMBER IS (B)(4), LOT NUMBER IS 2820031, EXPIRATION DATE IS MAY 31, 2012, UDI IS (B)(4). CORRECTION: THE PREVIOUSLY REPORTED PMA/510(K)# WAS INCORRECT. THE CORRECT PMA/510(K)# IS P960013. CORRECTION: THE PREVIOUSLY REPORTED DEVICE MANUFACTURE DATE WAS INCORRECT. THE CORRECT DEVICE MANUFACTURE DATE IS JUL 4, 2009.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED FOR ROUTINE GENERATOR REPLACEMENT. THE ATRIAL LEAD WAS EXTRACTED AND REPLACED DUE TO HIGH THRESHOLD AND PHRENIC NERVE STIMULATION. IT WAS NOTED THAT PHRENIC NERVE STIMULATION WAS ALSO OBSERVED WITH THE NEW LEAD EXCEPT WITH HIGH SEPTAL PLACEMENT. THE PATIENT WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED FOR ROUTINE GENERATOR REPLACEMENT. THE RIGHT VENTRICULAR LEAD WAS EXTRACTED AND REPLACED DUE TO HIGH THRESHOLD AND PHRENIC NERVE STIMULATION. IT WAS NOTED THAT PHRENIC NERVE STIMULATION WAS ALSO OBSERVED WITH THE NEW LEAD EXCEPT WITH HIGH SEPTAL PLACEMENT. THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985570 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1888TC/58 2820031 05414734501750

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention