MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD UNIFY CRT-D, DF-4 CONNECTOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3231-40Q

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Cardiopulmonary Arrest (1765); Cyanosis (1798); Death (1802)

Event Date 11/08/2014

Event Type  Death  

Event Description

New information received notes that the patient was found unresponsive, apneic, and cyanotic.Ems found the patient to be in complete pulmonary arrest; the monitor revealed pulseless electrical activity.Cpr was initiated during transport to the hospital where the patient was intubated.Cardiac ultrasound revealed cardiac standstill, with no spontaneous cardiac activity or pulse.Device pacing spikes were observed on the monitor.Cpr was continued but the patient expired.The cause of death was determined to be acute cardiopulmonary arrest.

Event Description

It was reported that the patient expired due to a cardiac arrhythmia related issue.There is no known allegation from a health professional that the death was related to the device.No further information is available at this time.

Manufacturer Narrative

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.(b)(4).

• Brand Name: UNIFY CRT-D, DF-4 CONNECTOR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sharon mathew ; 645 almanor avenue; sunnyvale, CA 94085 ; 4085226327
• MDR Report Key: 4382414
• MDR Text Key: 5184543
• Report Number: 2938836-2015-00069
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2012
• Device Model Number: CD3231-40Q
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2014
• Initial Date FDA Received: 01/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: (B)(4)
• Patient Outcome(s): Death
• Patient Age: 67 YR