BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 2954433 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-02283
    Event Type
    Death
    Date Received
    February 11, 2013
    Date of Event
    December 18, 2012
    Report Date
    July 29, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    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).

    Additional Manufacturer Narrative · 1

    FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT IS DECEASED AND DIED FOUR DAYS LATER AND APPROXIMATELY FOUR MONTHS POST IMPLANT OF THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM. THE PATIENT WAS NOTED TO BE IN RESPIRATORY DISTRESS AND ON A VENTILATOR WHEN THE LOSS OF VENTRICULAR CAPTURE WAS NOTED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN REPORTED THE PATIENT WAS ADMITTED DUE TO AN OUT OF HOSPITAL CARDIAC ARREST FROM A CHOKING EPISODE. THE PATIENT SUFFERED ANOXIC ENCEPHALOPATHY AS A RESULT DESPITE HYPOTHERMIA PROTOCOL. ON ADMISSION NORMAL EJECTION FRACTION WAS PRESENT. THE PATIENT DIED FROM CARDIOPULMONARY ARREST/ANOXIC ENCEPHALOPATHY. THE PHYSICIAN REPORTED THE DEATH WAS UNRELATED TO THE DEVICE SYSTEM AND THE LOSS OF CAPTURE IS REPORTED TO BE RELATED TO THE PATIENT'S MEDICAL CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY REMOTE TRANSMISSION THE VENTRICULAR LEAD HAD LOSS OF CAPTURE IN THE STORED DIAGNOSTICS. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58262 CAPSUREFIX MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI58

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Death| H| L RVDR01 IMPLANTABLE PULSE GENERATOR (IPG)