BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2952819 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00716
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    September 20, 2012
    Report Date
    February 7, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYSIS FOUND NO ANOMALIES. HOWEVER, THE PROXIMAL CONDUCTOR WAS KINKED/BUCKLED AND HAD BLOOD ON IT (NOT OBSTRUCTED). THE OUTER INSULATION WAS CUT. VISUAL ANALYSIS NOTED APPARENT EXPLANT DAMAGE. THE LEAD WAS RETURNED WITH THE ANCHORING SLEEVE ON THE DISTAL END OF THE LEAD. THE ANALYST COULD NOT PERFORM HELIX EXTENSION/RETRACTION/LENGTH TESTING DUE TO THE CONDITION OF THE RETURNED LEAD. DURING EXPLANT IT APPEARS THAT THE PROXIMAL CONDUCTOR WAS DISTORTED AND IS PRESSING ON THE INNER INSULATION AND THE DISTAL CONDUCTOR. THIS IS PREVENTING THE HELIX FROM EXTENDING OR RETRACTION WHEN THE PIN IS ROTATED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE 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)(64.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE ONE-YEAR DEVICE FOLLOW-UP A "STIMULATION DEFAULT" WAS FOUND ON BOTH LEADS. THE LEADS WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57013 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 4076 IMPLANTABLE PACING LEAD