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

Model Number CD3265-40Q

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

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

Event Date 11/15/2014

Event Type  Death  

Event Description

It was reported that the patient expired.The patient was hospitalized after being found in the nursing home pulseless and unresponsive.The patient was intubated and cpr was initiated.The patient did not regain consciousness.An ecg showed ventricular pacing.A scan was negative for a cerebral event.The emergency dept note stated that the patient presented with respiratory arrest and that the arrest was witnessed.The patient had a pulse upon presentation to the er.The events leading up to the cardiac arrest are unknown.The death was classified as non-cardiac, and the patient had worsening heart failure, as an x-ray showed pulmonary edema.There is no allegation from a health professional that the death was related to the device.

• 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: 4359240
• MDR Text Key: 20755582
• Report Number: 2938836-2014-19153
• 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
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2014
• Device Model Number: CD3265-40Q
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2013
• 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: 88 YR