BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3991641 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08004
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    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 THE DISTAL END/ELECTRODES OF THE LEAD WERE BENT, THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A TEAR AND VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. ELECTRICAL RESISTANCE AND CROSS CONTINUITY TEST RESULTS WERE WITHIN SPECIFICATION. HELIX CANNOT BE EXTEND/ RETRACT DUE TO SENSE ELECTRODE BENT.

    Additional Manufacturer Narrative · 1

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

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THERE WERE MULTIPLE RIGHT VENTRICULAR (RV) LEAD REPOSITION ATTEMPTS AND HELIX EXT ENSION/RETRACTIONS AND THE LEAD IMPEDANCE WAS GREATER THAN 4000 OHMS. THE LEAD WAS NOT USED AND ANOTHER LEAD WAS SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471116 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR