BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2952596 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00642
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 19, 2012
    Report Date
    January 30, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED AND ANALYSIS FOUND NO ANOMALIES. HOWEVER, IT WAS NOTED THAT THE DISTAL ELECTRODE WAS COVERED IN BLOOD. VISUAL ANALYSIS NOTED THAT THE LEAD WAS RECEIVED WITH STYLET IN THE LEAD AND THE HELIX BENT. THE BENT HELIX IS LIKELY DUE TO ATTEMPTED IMPLANT DAMAGE. DUE TO THE HELIX BEING BENT, THE EXTENSION/RETRACTION AND LENGTH TESTING COULD NOT BE PERFORMED.

    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 AT THE IMPLANT PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD WAS POSITIONED AND WHEN THE ATRIAL LEAD WAS ATTEMPTED TO BE PLACED IT WAS VERY DIFFICULT TO MOVE. THERE WAS A REMARKABLE COMPRESSION OF ONE LEAD AGAINST THE OTHER WHICH MADE REPOSITIONING NOT POSSIBLE. BOTH LEADS WERE EXPLANTED. THE HELIX ON THE RV LEAD WOULD NOT FULLY RETRACT SO A NEW RV LEAD WAS USED AND THE PATIENT WAS DOWNGRADED TO A VVI DEVICE DUE TO THE ANATOMICAL CONSTRAINTS SO THERE WAS NO NEED FOR A NEW ATRIAL LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55397 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR