BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1735486 · Received June 24, 2010

    Report

    Report Number
    2649622-2010-06846
    Event Type
    Death
    Date Received
    June 24, 2010
    Date of Event
    April 19, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, 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. EVALUATION SUMMARY (B)(4) NO ANOMALIES FOUND. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A HISTORY OF ISCHEMIC CARDIOMYOPATHY, SEVERE LV (LEFT VENTRICULAR) DYSFUNCTION, AND WAS NOT PACEMAKER DEPENDENT. THE PATIENT REFUSED AN ICD, SO A PACEMAKER WAS IMPLANTED. THE PATIENT HAD BEEN SEEN THE DAY AFTER IMPLANT AND THEN 5 DAYS LATER ARRIVED TO THE ER UNRESPONSIVE AND IN PEA (PULSELESS ELECTRICAL ACTIVITY). THE PATIENT WAS NOT ABLE TO BE RESUSCITATED AND DIED IN THE ER. FOLLOW UP WITH THE HEALTH CARE PROFESSIONAL REPORTED THE CAUSE OF DEATH TO BE AN MI (MYOCARDIAL INFARCTION) WITH VF ARREST, LOW EF (EJECTION FRACTION) , CAD (CORONARY ARTERY DISEASE), AND RENAL FAILURE. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death