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

Model Number CD3365-40C

Device Problems No Device Output (1435); Defibrillation/Stimulation Problem (1573)

Patient Problems Death (1802); Dyspnea (1816); Pneumothorax (2012); Ventricular Tachycardia (2132)

Event Date 10/01/2017

Event Type  Death  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that there was an unspecified issue with the lv lead and was scheduled for a lead revision however the physician stopped the procedure due to occlusion on (b)(6) 2017, the patient was admitted to the hospital due to shortness of breath.While in the hospital, the patient went into ventricular tachycardia but the device did not deliver a shock.Medication was unsuccessful to convert the patient¿s rhythm and so the patient was given an external shock and then admitted to the icu.The patient developed pneumothorax and was given a chest tube.On (b)(6) 2017, the chest tube was removed and the patient was placed on a ventilator.The patient¿s wife believes that placing the patient on a ventilator may have damaged the lung.The patient passed away due to respiratory failure.

Manufacturer Narrative

Health professional should have been - yes - rather than no.Occupation should have been physician.Should have been - unknown - for reported to the fda.

Manufacturer Narrative

(b)(4).

• Brand Name: QUADRA ASSURA CRT-D QUAD RF HV
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7287623
• MDR Text Key: 100640015
• Report Number: 2017865-2018-02691
• 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,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: CD3365-40C
• Device Catalogue Number: CD3365-40C
• Device Lot Number: A000032129
• Other Device ID Number: 05414734508261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2016
• 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; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 89