BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 2964774 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02203
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    November 7, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    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. (B)(4). CONCOMITANT CONTINUED: 5554 IMPLANTABLE PACING LEAD (B)(6) 2004.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THERE IS AN "ERROR THAT COMES UP ON ONE OF YOUR LEADS" AND "SOMETHING ABOUT THE FREQUENCY BEING TOO HIGH.". THE PATIENT FURTHER REPORTED THAT AT TIMES THE DEVICE FEELS LIKE A "HARD DRIVE RUNNING" AND IT SOMETIMES "SKIPS A BEAT"AND THE PATIENTS "HEART JUST STOPS". THE DEVICE AND 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
    68943 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5054-52

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ED2DR01 IMPLANTABLE PULSE GENERATOR