BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 5860834 · Received August 9, 2016

    Report

    Report Number
    2649622-2016-09447
    Event Type
    Malfunction
    Date Received
    August 9, 2016
    Date of Event
    June 28, 2016
    Report Date
    June 28, 2016
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. THE DISTAL CONDUCTOR OF THE LEAD WAS EXTRINSICALLY OVER-ROTATED. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. THE ANALYST COMMENTED THAT THE HELIX COULD NOT BE EXTENDED OR RETRACTED AND STYLET INSERTION FAILED DUE TO THE DISTAL CONDUCTOR DISTORTION WITHIN THE IS-1 CONNECTOR PIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PLACEMENT DIFFICULTY WAS EXPERIENCED WHILE ATTEMPTING TO IMPLANT THE PACING LEAD. THE HELIX DID NOT EXTEND OR RETRACT PROPERLY AND THE STYLET COULD NOT BE ADVANCED TO THE LEAD TIP. THE LEAD WAS REMOVED AND A DIFFERENT LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508570 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR