MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUADRA ASSURA CRT-D QUAD RF HV; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3365-40Q

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

Patient Problems Rheumatoid Arthritis (1724); Congestive Heart Failure (1783); Death (1802)

Event Date 09/09/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient expired.There is no known allegation from a health professional that suggests the death was related to the device.The cause of death on death certificate notes congestive heart failure, rheumatoid arthritis, hypertensive heart disease and interstitial lung disease.The manner of death was natural.

Manufacturer Narrative

Analysis was normal.No anomalies were found.

• Brand Name: QUADRA ASSURA CRT-D QUAD RF HV
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: jaime chavez ; 645 almanor avenue; sunnyvale, CA 94085 ; 8184934022
• MDR Report Key: 6057278
• MDR Text Key: 58397784
• Report Number: 2938836-2016-13045
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/29/2016

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: No Information
• Device Expiration Date: 03/31/2016
• Device Model Number: CD3365-40Q
• Device Lot Number: 4525754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2016
• Initial Date FDA Received: 10/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2014
• 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); (B)(4); (B)(4)
• Patient Outcome(s): Death
• Patient Age: 62 YR