BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONSULTA

    MDR report key: 1654712 · Received April 9, 2010

    Report

    Report Number
    6000144-2010-01543
    Event Type
    Death
    Date Received
    April 9, 2010
    Date of Event
    March 31, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY (B) (4) WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THE VENTRICULAR IMPEDANCE MEASUREMENT WAS IN THE 400 - 500 OHM RANGE UNTIL THE LAST READING ON (B) (6) 2010 WHEN THE VALUE WAS 76 OHMS. THE ATRIAL PACE IMPEDANCE MEASUREMENT WAS IN THE 400 - 500 OHM RANGE EXCEPT FOR THE LAST READING ON (B) (6) 2010 WHEN THE VALUE WAS 57 OHMS. (B) (4) NO ANOMALIES FOUND. PARTIAL LEAD IN SEGMENTS RETURNED AND ANALYZED. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY (B) (4) WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THE VENTRICULAR IMPEDANCE MEASUREMENT WAS IN THE 400 - 500 OHM RANGE UNTIL THE LAST READING ON (B) (6) 2010 WHEN THE VALUE WAS 76 OHMS. THE ATRIAL PACE IMPEDANCE MEASUREMENT WAS IN THE 400 - 500 OHM RANGE EXCEPT FOR THE LAST READING ON (B) (6)2010 WHEN THE VALUE WAS 57 OHMS.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY (B) (4) WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THE VENTRICULAR IMPEDANCE MEASUREMENT WAS IN THE 400 - 500 OHM RANGE UNTIL THE LAST READING ON (B) (6) 2010 WHEN THE VALUE WAS 76 OHMS. THE ATRIAL PACE IMPEDANCE MEASUREMENT WAS IN THE 400 - 500 OHM RANGE EXCEPT FOR THE LAST READING ON (B) (6) 2010 WHEN THE VALUE WAS 57 OHMS.

    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) - WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THE VENTRICULAR IMPEDANCE MEASUREMENT WAS IN THE 400 - 500 OHM RANGE UNTIL THE LAST READING ON (B)(6) 2010 WHEN THE VALUE WAS 76 OHMS. THE ATRIAL PACE IMPEDANCE MEASUREMENT WAS IN THE 400 - 500 OHM RANGE EXCEPT FOR THE LAST READING ON (B)(6) 2010 WHEN THE VALUE WAS 57 OHMS. (B)(4) NO ANOMALIES FOUND. PARTIAL LEAD IN SEGMENTS RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND. PROXIMAL SEGMENT RETURNED AND ANALYZED. DEVICE WAS RETURNED AFTER PATIENT DEATH WITH LOW IMPEDANCE AND PATIENT ALERT. FURTHER ANALYSIS REVEALED, THE LOW LEAD IMPEDANCE FAILURE NOTED WAS CONFIRMED AND WAS SHOWN TO BE RELATED TO AN ANOMALOUS VALUE. THE ANOMALOUS VALUE WAS FOUND TO BE DUE TO A GATE OXIDE FAILURE IN THE TRANSISTOR.

    Description of Event or Problem · 1

    (B) (4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT CALLED THE CLINIC AFTER HEARING THE ALARM GOING OFF. A CARELINK TRANSMISSION WAS SENT THAT SHOWED AN ATRIAL IMPEDANCE OF 57 OHMS AND RIGHT VENTRICULAR IMPEDANCE OF 76 OHMS. "THEY WERE NORMAL PRIOR TO THIS TRANSMISSION." PATIENT IS COMPLETELY PACER DEPENDENT. THE PATIENT WAS ADVISED TO COME TO THE HOSPITAL AND DIED WHILE DRIVING THERE. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP WITH MANUFACTURER'S REPRESENTATIVE REVEALED THE "CORONER SAID CAUSE OF DEATH WAS NATURAL CAUSES, THE CLINIC STAFF BELIEVE IT WAS DEVICE RELATED, BUT NEED TO RULE LEAD FAILURE."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT CALLED CLINIC AFTER HEARING ALARM GOING OFF. CARELINK TRANSMISSION SENT THAT SHOWED AN ATRIAL IMPEDANCE OF 57 OHMS AND RIGHT VENTRICULAR IMPEDANCE OF 76 OHMS. "THEY WERE NORMAL PRIOR TO THIS TRANSMISSION." PATIENT IS COMPLETELY PACER DEPENDENT. PATIENT ADVISED TO COME TO HOSPITAL AND DIED WHILE DRIVING THERE. CAUSE OF DEATH REQUESTED AND NOT RECEIVED. FOLLOW UP WITH MANUFACTURER'S REPRESENTATIVE REVEALED "CORONER SAID CAUSE OF DEATH WAS NATURAL CAUSES, THE CLINIC STAFF BELIEVE IT WAS DEVICE RELATED, BUT NEED TO RULE LEAD FAILURE." ATTORNEY LATER ALLEGED "PATIENT RECEIVED ALARMS FROM DEVICE, CONTACTED PHYSICIAN AND SENT CARELINK TRANSMISSION AND THEN WAS DIRECTED TO GO TO DR.???S OFFICE. ON THE WAY (4 HOUR DRIVE) PATIENT DIED."

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT CALLED THE CLINIC AFTER HEARING THE ALARM GOING OFF. A CARELINK TRANSMISSION WAS SENT THAT SHOWED AN ATRIAL IMPEDANCE OF 57 OHMS AND RIGHT VENTRICULAR IMPEDANCE OF 76 OHMS. "THEY WERE NORMAL PRIOR TO THIS TRANSMISSION." PATIENT COMPLETELY PACER DEPENDENT. THE PATIENT WAS ADVISED TO COME TO THE HOSPITAL AND DIED WHILE DRIVING THERE. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSULTA IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D224TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death LEAD/STJ IMPLANTABLE PACING LEAD| LEAD/STJ IMPLANTABLE PACING LEAD| LEAD/STJ IMPLANTABLE PACING LEAD| LEAD/STJ IMPLANTABLE PACING LEAD| LEAD/STJ IMPLANTABLE PACING LEAD