BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2786010 · Received October 12, 2012

    Report

    Report Number
    2649622-2012-13580
    Event Type
    Injury
    Date Received
    October 12, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE CHECK, IT WAS NOTED THAT THE RHYTHM WAS P-WAVE FOLLOWED BY R-WAVE, BUT THE DEVICE UNDERSENSED THE ATRIAL EVENT AND THE ATRIAL PACING RESULTED IN VENTRICULAR CAPTURE. AN ATRIAL LEAD DISLODGMENT WAS SUSPECTED. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE CHECK, IT WAS NOTED THAT THE RHYTHM WAS P-WAVE FOLLOWED BY R-WAVE, BUT THE DEVICE UNDERSENSED THE ATRIAL EVENT AND THE ATRIAL PACING RESULTED IN VENTRICULAR CAPTURE. AN ATRIAL LEAD DISLODGMENT WAS SUSPECTED. IT WAS FURTHER REPORTED THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK. IT WAS SUSPECTED THAT THE ATRIAL LEAD DISLODGEMENT WAS AFFECTING THE RIGHT VENTRICULAR (RV) LEAD. BOTH LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening| O D314DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6947 IMPLANTABLE TACHY LEAD| D314DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB