BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3152700 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06700
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE OF THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED; NO ANOMALIES WERE FOUND. THE ANALYST COMMENTED THAT THE PROXIMAL CONDUCTOR OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO PULLING/STRETCHING/OVERSTRESS, THE DISTAL CONDUCTOR OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO PULLING/STRETCHING/OVERSTRESS AND THE DISTAL CONDUCTOR OF THE LEAD WAS OBSTRUCTED DUE TO A STYLET/GUIDEWIRE STUCK IN THE LUMEN. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. 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 PROCEDURE, TWO LEADS WERE FOUND TO BE FRACTURED. THE LEADS WERE NOT IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT DURING THE IMPLANT PROCEDURE, NOISE APPEARED ON THE LEADS AND THE IMPEDANCE WAS "ON THE LOW SIDE." ADDITIONALLY, ONE OF THE LEADS WAS FOUND TO BE CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252241 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1