BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 6196321 · Received December 21, 2016

    Report

    Report Number
    2649622-2016-16441
    Event Type
    Death
    Date Received
    December 21, 2016
    Date of Event
    December 18, 2016
    Report Date
    December 18, 2016
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00643169550766
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 THE PATIENT IS DECEASED. IT WAS ALSO REPORTED THAT AFTER THE IMPLANT PROCEDURE WAS COMPLETE, THE PATIENT WAS MOVED FROM THE TABLE AND THE PATIENT¿S BLOOD PRESSURE DROPPED ¿TOO LOW TO MEASURE.¿ A ¿CODE BLUE¿ WAS CALLED AND CARDIOPULMONARY RESUSCITATION (CPR) WAS STARTED. AN ECHOCARDIOGRAM REVEALED THERE WAS NOT A PERFORATION. THE PATIENT ¿STARTED TO AWAKE¿ AND AT THIS TIME FLUOROSCOPY REVEALED THE LEADS DISLODGED. IT WAS DETERMINED THE DISLODGMENT RESULTED FROM CPR. THE INTENTION WAS TO CORRECT THE DISLODGMENT; HOWEVER, THE PATIENT ¿CRASHED AND COULD NOT BE REVIVED.¿ THE PHYSICIAN STATED THE PATIENT WAS VERY ILL AND DID NOT THINK THE IMPLANT WAS RELATED TO THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845745 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52 00643169550766

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death DDMB1D4 ICD, 6935M62 LEAD