BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3152297 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06868
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 18, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY - THE FULL LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4).

    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 ATTEMPT, THE HELIX OF THE LEAD WOULD NOT ADVANCE SMOOTHLY. THE LEAD WAS NOT USED. A NEW LEAD WAS ATTEMPTED AND THE GUIDEWIRE WOULD NOT INSERT ALL THE WAY AND THERE WAS ALSO BAD SENSING. THAT LEAD WAS NOT USED. THE PHYSICIAN ALSO STATED THAT THERE WAS DIAPHRAGMATIC STIMULATION WITH BOTH LEADS. A NEW 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
    252955 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1