BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE EPI

    MDR report key: 1669405 · Received April 29, 2010

    Report

    Report Number
    2182208-2010-00186
    Event Type
    Death
    Date Received
    April 29, 2010
    Date of Event
    March 25, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. FOLLOW UP REVEALED THE CAUSE OF DEATH TO BE CARDIAC RIGHT VENTRICULAR HYPERTROPHY WITH MYOCARDIAL FAILURE, STENOTIC RIGHT VENTRICULAR / PULMONARY CONDUIT OUTFLOW, HYPERTROPHIC SUBPULMONARY RING INFUNDIBULAR BAR, IN ASSOCIATION WITH RIGHT VENTRICULAR HYPERTROPHY, STATUS POST REPAIR OF TETRALOGY OF FALLOT WITH WITH PULMONARY ATRESIA.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REPROGRAMMING OF THE ATRIAL LEAD SENSITIVITY HAD BEEN DONE OVER THE PAST YEAR DUE TO ATRIAL OVERSENSING. THE ATRIAL LEAD HAD SHOWN A DECLINE IN IMPEDANCE FROM 240 OHMS TO 180 OHMS OVER THE PREVIOUS 4 MONTHS. THE VENTRICULAR LEAD IMPEDANCE SHOWED A DECREASE IN IMPEDANCE FROM 300 TO 260 OHMS OVER THE PREVIOUS 3 MONTHS. THE PATIENT HAD BEEN SEEN IN THE CLINIC EVERY 3 - 4 MONTHS OVER THE PAST FEW YEARS AND TWICE IN (B) (6) 2010. THE PATIENT IS REPORTED TO HAVE DIED (B) (6) 2010. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REPROGRAMMING OF THE ATRIAL LEAD SENSITIVITY HAD BEEN DONE OVER THE PAST YEAR DUE TO ATRIAL OVERSENSING. THE ATRIAL LEAD HAD SHOWN A DECLINE IN IMPEDANCE FROM 240 OHMS TO 180 OHMS OVER THE PREVIOUS 4 MONTHS. THE VENTRICULAR LEAD IMPEDANCE SHOWED A DECREASE IN IMPEDANCE FROM 300 TO 260 OHMS OVER THE PREVIOUS 3 MONTHS. THE PATIENT HAD BEEN SEEN IN THE CLINIC EVERY 3 - 4 MONTHS OVER THE PAST FEW YEARS AND TWICE IN (B) (6) 2010. THE PATIENT IS REPORTED TO HAVE DIED (B) (6) 2010. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. 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 CAPSURE EPI IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 4965 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Death ADDRS1 IMPLANTABLE PULSE GENERATOR