BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2964923 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02141
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    December 18, 2012
    Report Date
    March 8, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. THE LEAD WAS RETURNED WITH EXTRINSIC BREACH-CUT AT THE ANCHORING SLEEVE LOCATION AND WITH A CONSIDERABLE AMOUNT OF DRIED BLOOD ON THE PROXIMAL CONDUCTOR. THE NATURE OF THE CUTS (BOTH HORIZONTAL AND VERTICAL) AND THE AMOUNT OF BLOOD INDICATES THAT THE DAMAGE LIKELY OCCURRED DURING THE IMPLANT, AND IS LIKELY THE REASON FOR THE DECREASED SENSING/INCREASED CAPTURE THRESHOLD MENTIONED IN THE EVENT. HELIX EXTENSION/RETRACTION AND LENGTH TESTING WERE PERFORMED AND ALL RESULTS, INCLUDING ELECTRICAL TESTING, WERE WITHIN SPECIFIED PARAMETERS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD DECREASED SENSING AND AN INCREASED CAPTURE THRESHOLD. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD DECREASED SENSING AND AN INCREASED CAPTURE THRESHOLD. THE LEAD WAS EXPLANTED 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
    68146 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Hospitalization| R