BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3990290 · Received August 7, 2014

    Report

    Report Number
    2649622-2014-08722
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    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. CONCOMITANT PRODUCT: 5075-45 LEAD, IMPLANTED: (B)(6) 2009.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SYNCOPAL EPISODE WHILE WALKING TO THE KITCHEN, AND THEN AGAIN WHILE IN THE AMBULANCE AND AT THE EMERGENCY ROOM, WITH HEART BLOCK ALSO NOTED. NOISE, OVERSENSING, AND A POSSIBLE LEAD FRACTURE WERE NOTED. A TEMPORARY PACEMAKER WAS UTILIZED UNTIL THE NEXT MORNING, WHEN THE RV (RIGHT VENTRICULAR) LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463310 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| L| R ADDR01 IPG