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

Model Number CD3365-40Q

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

Patient Problems Cardiac Arrest (1762); Death (1802); Respiratory Failure (2484)

Event Date 02/02/2015

Event Type  Death  

Manufacturer Narrative

Device evaluation anticipated, but not yet begun.

Event Description

It was reported that the patient presented in the operating room for an av node ablation and crt-d system implant.The av node ablation was performed first and proceeded without incident.The physician then progressed to the lv lead implant and connected the lead to a new device.The pocket was closed after all testing resulted in normal values.The patient became unresponsive after being moved off the table.Cpr was performed but the patient could not be revived.The cause of death was attributed to respiratory arrest followed by cardiac arrest.There is no suspected device malfunction, but the physician claimed the surgery contributed to the death.

Manufacturer Narrative

(b)(4).

• Brand Name: QUADRA ASSURA 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: 4537433
• MDR Text Key: 17381077
• Report Number: 2938836-2015-01720
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup,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: 11/30/2016
• Device Model Number: CD3365-40Q
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/03/2015
• Initial Date FDA Received: 02/23/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/17/2015; 03/18/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/13/2014
• 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
• Patient Outcome(s): Death
• Patient Age: 80 YR