BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2953230 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00997
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE HELIX WAS DISTORTED FROM BEING PULLED/STRETCHED/OVERSTRESSED AND THE LEAD HAD APPARENT IMPLANT DAMAGE. THE ANALYST COMMENTED THAT THE LEAD WAS RETURNED WITH STYLET IN THE LEAD, THE HELIX EXTENDED AND THE HELIX APPEARING STRETCHED, LIKELY DUE TO ATTEMPTED IMPLANT DAMAGE FROM MULTIPLE ATTEMPTS. HELIX AS RETRACTED AND HELIX EXTENSION/RETRACTION AND LENGTH TESTING WERE PERFORMED. PINCH ON TOOL RETURNED WITH THE LAD WASUSED IN THE TESTING. HELIX LENGTH WAS OUT OF SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (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 IMPLANT, THE RIGHT ATRIAL (RA) LEAD HAD TO BE REPOSITIONED 8-10 TIMES AND THERE WAS MULTIPLE HELIX EXTENSIONS. THE STABILITY OF THE LEAD AND THE FUNCTION OF THE LEAD HELIX WERE QUESTIONED. THE RA LEAD WAS REMOVED 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
    55762 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407645

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR