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 Death (1802); Dyspnea (1816); Loss of consciousness (2418)

Event Date 11/27/2014

Event Type  Death  

Event Description

It was reported that the patient became short of breath and collapsed while walking.Immediate resuscitation attempts failed and the patient expired.There is no known allegation from a health professional that the death was related to the device.It was reported that the cause of death was unknown.No further information is available at this time.

Manufacturer Narrative

Device evaluation anticipated, but not yet begun.

• 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: 4417087
• MDR Text Key: 5165074
• Report Number: 2938836-2015-00588
• 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,company representative
• Reporter Occupation: Other
• 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: 08/31/2012
• Device Model Number: CD3231-40Q
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/19/2014
• Initial Date FDA Received: 01/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/18/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/17/2011
• 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
• Patient Outcome(s): Death
• Patient Age: 68 YR