BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 5858649 · Received August 9, 2016

    Report

    Report Number
    2649622-2016-08322
    Event Type
    Malfunction
    Date Received
    August 9, 2016
    Date of Event
    May 13, 2016
    Report Date
    May 13, 2016
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #ANALYSIS INFORMATION -- ON (B)(4) 2016 18:03:40 CST PLI# 10 PRODUCT ID# 5076-58 THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. THE DISTAL CONNECTOR OF THE LEAD WAS EXTRINSICALLY BENT. THE DISTAL CONDUCTOR WAS OBSTRUCTED DUE TO STYLET/GUIDEWIRE. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. THE ANALYST NOTED THAT THE LEAD WAS RETURNED DAMAGED. THE IS-1 PIN WAS BENT AND THE STYLET WAS STUCK IN LEAD AND COULD NOT BE REMOVED. THEREFORE, HELIX FUNCTIONS COULD NOT BE TESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REPLACEMENT PROCEDURE, A RIGHT VENTRICULAR (RV) LEAD WAS ATTEMPTED BUT NOT USED. THE PHYSICIAN NOTED THAT THE HELIX WOULD NOT EXTEND, EVEN AFTER OVER THIRTY TURNS. THE LEAD WAS NEVER IMPLANTED AND NEW LEAD WAS USED INSTEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512438 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR