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

Model Number CD3249-40Q

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

Patient Problems Death (1802); Hypoxia (1918); Respiratory Failure (2484)

Event Date 01/20/2014

Event Type  Death  

Event Description

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

All information provided by manufacturer, no medwatch form was received.

Event Description

New information received notes that the patient was admitted to the hospital for hypoxia and difficulty breathing.The cause of death was reported as acute on chronic respiratory failure secondary to a combination of congestive heart failure, chronic obstructive pulmonary disease, obstructive sleep apnea, pulmonary hypertension, morbid obesity, and aspiration pneumonia.

• Brand Name: UNIFY QUADRA 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: cary lawler ; 645 almanor avenue; sunnyvale, CA 94085 ; 8184932621
• MDR Report Key: 3781784
• MDR Text Key: 4436309
• Report Number: 2938836-2014-09972
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2014
• Device Model Number: CD3249-40Q
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2013
• 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: 73 YR