BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 6779278 · Received August 9, 2017

    Report

    Report Number
    2649622-2017-07685
    Event Type
    Malfunction
    Date Received
    August 9, 2017
    Date of Event
    May 3, 2017
    Report Date
    May 8, 2017
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE IMPLANT ATTEMPT, THE LEAD EXHIBITED PLACEMENT DIFFICULTY. THE PHYSICIAN FELT THAT, UPON DEPLOYMENT OF THE HELIX, THE PINCH-ON TOOL WAS TRANSMITTING TORQUE TO THE LEAD BODY CAUSING THE HELIX IT TO SPIN AWAY FROM THE CHAMBER WALL. THE LEAD WAS REPLACED WITH A DIFFERENT ONE; HOWEVER, THE SECOND LEAD THAT WAS ATTEMPTED EXHIBITED HIGH THRESHOLDS. BOTH LEADS WERE REMOVED AND THE PHYSICIAN CHOSE TO IMPLANT A SINGLE CHAMBER PACEMAKER INSTEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558286 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1