BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2955174 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-00776
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    November 28, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 419488 IMPLANTABLE PACING LEAD (B)(6) 2008; 694765 IMPLANTABLE TACHY LEAD (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    FOLLOW-UP WAS CONDUCTED AND FROM THE INFORMATION OBTAINED IT WAS REPORTED THAT THE CAUSE OF ATRIAL UNDERSENSING WAS DETERMINED TO BE THE OUTCOME OF AN ATRIAL ABLATION PROCEDURE PERFORMED PRIOR TO THIS EVENT. AT THE RECENT FOLLOW-UP THE ATRIAL LEAD IS SENSING APPROPRIATELY. THE PHYSICIAN BELIEVES TRAUMA FROM THE RFA PROCEDURE RESULTED IN THE OBSERVED UNDERSENSING. THE LEAD CONTINUES TO REMAIN IN USE.NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS INTERMITTENT ATRIAL UNDERSENSING ON THE ATRIAL LEAD. IT WAS ALSO NOTED THAT THERE WAS A TACHY EPISODE WHERE WAVELET MATCHES WERE GOOD, GREATER THAN EIGHTY PERCENT, BUT THE VENTRICULAR RATE WAS GREATER THAN ATRIAL DUE TO ATRIAL UNDERSENSING. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58285 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 D314TRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB