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

Model Number CD3365-40Q

Device Problems No Device Output (1435); Failure to Sense (1559)

Patient Problems Death (1802); Ventricular Tachycardia (2132)

Event Date 06/23/2017

Event Type  Death  

Event Description

It was reported that the device and leads exhibited complete loss of sensing.It was also noted that the patient deceased on (b)(6) 2017 due to ventricular arrhythmia that the device failed to sense or respond to.The session interrogation of (b)(6) 2017 was sent for review however the session reviewed first was from (b)(6) 2017 which showed appropriate detection of vt and delivery of hv therapy in a timely manner converting the rhythm.However from (b)(6) 2017, a nsvt episode and subsequent automatic mode switch episodes showed what appears to be complete loss of sensing on all egm channels and the device began measuring all impedance measurements out of range at this time.Due to this undersensing there were no vt/vf episodes noted on the date of the patients death.The device delivered 16 patient notifiers but the device was not interrogated until the day of the patients death with the most recent interrogation prior to (b)(6) 2017 being on (b)(6) 2017.It was noted that this behavior may be indicative of either all three leads fracturing or all leads dislodging, noting that the dislodgement is much more likely.No additional information was available.

Manufacturer Narrative

Should have been reported as (b)(6) 2017.

Manufacturer Narrative

The reported event of loss of sensing could not be determined.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-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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6774337
• MDR Text Key: 82060989
• Report Number: 2017865-2017-07744
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: CS
• PMA/PMN Number: P970013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: CD3365-40Q
• Device Catalogue Number: CD3365-40Q
• Device Lot Number: S000027948
• Other Device ID Number: 05414734508292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2016
• 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
• Treatment: (B)(4); (B)(4); (B)(4)
• Patient Outcome(s): Death