BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 12913804 · Received December 1, 2021

    Report

    Report Number
    3008377825-2021-00020
    Event Type
    Injury
    Date Received
    December 1, 2021
    Date of Event
    November 17, 2021
    Report Date
    April 20, 2022
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    UDI-DI
    05414734502870
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: D4 : CHANGED THE SERIAL NUMBER OF THE PRODUCT FROM (B)(6) TO (B)(6). ADDITIONAL INFORMATION: THE REPORTED EVENTS WERE LEAD DISLODGEMENT AND HIGH THRESHOLD. AS RECEIVED, A COMPLETE LEAD WAS RETURNED IN ONE PIECE WITH THE HELIX RETRACTED AND CLOGGED WITH BLOOD/TISSUE. AFTER CLEANING, THE HELIX COULD BE EXTENDED AND RETRACTED WHEN TORQUE APPLIED TO THE CONNECTOR PIN. THE FULL HELIX EXTENSION LENGTH WAS MEASURED WITHIN SPECIFICATIONS. THE REPORTED EVENT OF HIGH THRESHOLD WAS NOT CONFIRMED. ELECTRICAL TESTING DID NOT FIND ANY INDICATION OF CONDUCTOR FRACTURES OR INTERNAL SHORTS. VISUAL AND X-RAY EXAMINATION DID NOT FIND ANY ANOMALIES WITH THE EXCEPTION OF PROCEDURAL DAMAGE.

    Additional Manufacturer Narrative · 0

    CORRECTION: D3 - CHANGED MANUFACTURER INFORMATION ADDRESS TO ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FROM ST. JUDE MEDICAL OPERATIONS (M) SDN BHD. ADDITIONAL INFORMATION - H6- CONCLUSION CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT PRESENTED IN CLINIC WITH DISCOMFORT FROM PACING. UPON INTERROGATION, IT WAS OBSERVED THE PATIENT'S ATRIAL LEAD HAD HIGH CAPTURE THRESHOLDS. A CHEST X-RAY SHOWED THE PATIENT'S ATRIAL LEAD HAD DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED WITHOUT ISSUE. THE PATIENT WAS STABLE THROUGHOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1804891 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2088TC/46 P000117260 05414734502870

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention ASSURITY PACEMAKER| TENDRIL STS LEAD