BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2952801 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00712
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD ON THE DISTAL END ELECTRODES. THE ANALYSIS COMMENTS STATED THAT HELIX EXTENSION/RETRACTION AND LENGTH TESTING WERE PERFORMED AND ALL RESULTS, INCLUDING ELECTRICAL TESTING, WERE WITHIN SPECIFIED PARAMETERS.

    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)(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 THE LEAD WAS TRIED TO BE FIX THREE TIMES BUT THE VALUES WERE NOT GOOD ENOUGH. THEN WHEN A GOOD POSITION WAS FOUND AND THE LEAD WAS FIXED THE LEAD'S THRESHOLD MEASUREMENTS WERE VARIABLE. THE LEAD WAS THEN TRIED TO BE FIXED IN ANOTHER PLACE THREE TIMES WITH THE SAME OUTCOME. THE LEAD WAS REMOVED AND A NEW LEAD WAS IMPLANTED INSTEAD WITH GOOD ANDSTABLE THRESHOLDS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56819 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1