BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS LEAD MRI SURESCAN

    MDR report key: 8944471 · Received August 29, 2019

    Report

    Report Number
    2649622-2019-15531
    Event Type
    Malfunction
    Date Received
    August 29, 2019
    Date of Event
    August 5, 2019
    Report Date
    September 16, 2019
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00643169633759
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. THE ANALYSIS INDICATED THAT THE HELIX OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO PULLING/STRETCHING/OVERSTRESS. VISUAL ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT OF A RIGHT ATRIAL (RA) LEAD THERE WAS DIFFICULTY ADVANCING/ PLACING THE LEAD THROUGH THE SUBCLAVIAN VEIN (SCV). IT WAS NOTED THE LEAD WAS BUCKLING DURING ADVANCEMENT, A STYLET WAS ADDED FOR STIFFNESS HOWEVER THE ISSUE CONTINUED. THE LEAD WAS REMOVED AND DURING INSPECTION IT WAS OBSERVED THE HELIX WAS EXTENDED AND COULD NOT BE RETRACTED. A NEW LEAD WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738760 CAPSUREFIX NOVUS LEAD MRI SURESCAN ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52 00643169633759

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR