BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 6162933 · Received December 9, 2016

    Report

    Report Number
    2649622-2016-15400
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    May 1, 2016
    Report Date
    October 3, 2016
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: D334TRG ICD, IMPLANTED: (B)(6) 2013. 694758 LEAD, IMPLANTED: (B)(6) 2013. 620BG29 HEART BAND, IMPLANTED: (B)(6) 2012. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING AND NO CAPTURE AT HIGH OUT PUTS. IT WAS ALSO NOTED THAT THE LEAD HAD HIGH THRESHOLDS AND INCONSISTENT SENSING. THE LEAD WAS NOT ADEQUATELY SENSING ATRIAL FIBRILLATION (AF) AND NORMAL P-WAVES WHICH RESULTED IN INAPPROPRIATE PACING. DURING THE REPLACEMENT PROCEDURE, IT WAS DETERMINED THE LEAD WAS DISLODGED. THE LEAD APPEARED TO NOT BE FULLY SEATED IN THE APPENDAGE WITH NO SLACK IN THE LEAD. THE LEAD WAS CAPPED 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
    810765 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407645

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R 5071-53 LEAD