BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 10390147 · Received August 11, 2020

    Report

    Report Number
    2938836-2020-07861
    Event Type
    Injury
    Date Received
    August 11, 2020
    Report Date
    August 13, 2020
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVN
    UDI-DI
    05414734501750
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: E3. ADDITIONAL INFORMATION: E1.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS REGISTERED AS A COMBINATION PRODUCT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NOISE WAS NOTED AS HIGH VENTRICULAR RATES ON NTH RIGHT VENTRICULAR (RV) LEAD. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2020. THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855103 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 1888TC/52 3150618 05414734501750

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention