BEUDAMED
    FDA Adverse Event Death Summary report: N

    KAPPA 900 DR

    MDR report key: 1863478 · Received October 11, 2010

    Report

    Report Number
    2647346-2010-00675
    Event Type
    Death
    Date Received
    October 11, 2010
    Date of Event
    April 3, 2009
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/014
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. THE CAUSE OF DEATH HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED. IT IS NOT KNOWN IF THE DEVICE WAS EXPLANTED POST-MORTEM. AT THE TIME OF THE RETRO REVIEW, IT WAS NOTED IN THE MANUFACTURER'S DATABASE THAT THE PATIENT HAD DIED. THE ATRIAL LEAD WAS ADDED TO THE EVENT. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS FOUND APPROXIMATELY ONE HOUR AFTER DEATH AND BROUGHT TO THE EMERGENCY DEPARTMENT. INTERROGATION OF THE DEVICE IN THE FUNERAL HOME REVEALED HIGH RATE EPISODES, HIGH IMPEDANCE, AND VENTRICULAR LEAD WARNING ALERT A COUPLE DAYS BEFORE THE PATIENT DIED. A VENTRICULAR LEAD FRACTURE WAS SUSPECTED. ALSO REPORTED A LEAD WARNING OCCURRED DUE TO HIGH IMPEDANCES ON THE ATRIAL LEAD. A FRACTURE WAS SUSPECTED. INTERROGATION OF THE DEVICE ALSO REVEALED THE ATRIAL LEAD HAD BEEN TURNED OFF AND THE DEVICE PROGRAMMED AT VVIR. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP REVEALED THE PATIENT HAD A HISTORY OF NUMEROUS CONGENITAL HEART DEFECTS THAT HAD REQUIRED MULTIPLE SURGERIES. PATIENT WAS PACEMAKER DEPENDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE HAD BEEN A LEAD WARNING DUE TO HIGH IMPEDANCES ON ATRIAL LEAD ON (B)(6) 2005 WITH FRACTURE SUSPECTED. DEVICE INTERROGATION REVEALED ATRIAL LEAD TURNED OFF AND DEVICE PROGRAMMED AT VVIR. ALSO SHOWED HIGH RATE EPISODES, HIGH IMPEDANCE, AND VENTRICULAR LEAD WARNING ALERT A COUPLE DAYS BEFORE PATIENT DIED. VENTRICULAR LEAD FRACTURE SUSPECTED. FOLLOW UP REVEALED THE PATIENT HAD A HISTORY OF NUMEROUS CONGENITAL HEART DEFECTS THAT HAD REQUIRED MULTIPLE SURGERIES. PATIENT WAS PACEMAKER DEPENDENT. DEATH CERTIFICATE NOTES CAUSE OF DEATH AS POSSIBLE CARDIAC ARREST, COMPLETE ATRIOVENTRICULAR BLOCK, POSSIBLE LEAD MALFUNCTION, AND OTHER CONTRIBUTING FACTORS OF COARCTATION AND VSD REPAIR ((B)(6) 2003), SUBAORTIC STENOSIS REPAIR ((B)(6) 2004), PACEMAKER IMPLANT ((B)(6) 2004). PER PATIENT'S MEDICAL RECORD, FATHER FOUND THE PATIENT UNRESPONSIVE WITHOUT PULSE OR RESPIRATIONS IN BED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE HAD BEEN A LEAD WARNING DUE TO HIGH IMPEDANCES ON ATRIAL LEAD ON (B)(6) 2005 WITH FRACTURE SUSPECTED. DEVICE INTERROGATION REVEALED ATRIAL LEAD TURNED OFF AND DEVICE PROGRAMMED AT VVIR. ALSO SHOWED HIGH RATE EPISODES, HIGH IMPEDANCE, AND VENTRICULAR LEAD WARNING ALERT A COUPLE DAYS BEFORE PATIENT DIED. VENTRICULAR LEAD FRACTURE SUSPECTED. FOLLOW UP REVEALED THE PATIENT HAD A HISTORY OF NUMEROUS CONGENITAL HEART DEFECTS THAT HAD REQUIRED MULTIPLE SURGERIES. PATIENT WAS PACEMAKER DEPENDENT. DEATH CERTIFICATE NOTES CAUSE OF DEATH AS POSSIBLE CARDIAC ARREST, COMPLETE ATRIOVENTRICULAR BLOCK, POSSIBLE LEAD MALFUNCTION, AND OTHER CONTRIBUTING FACTORS OF COARCTATION AND VSD REPAIR ((B)(6) 2003), SUBAORTIC STENOSIS REPAIR ((B)(6) 2004), PACEMAKER IMPLANT ((B)(6) 2004).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAPPA 900 DR ASKU DXY MEDTRONIC MED REL, INC. KDR921 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Death