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 Problems Failure to Capture (1081); Premature End-of-Life Indicator (1480); Premature Elective Replacement Indicator (1483); Low impedance (2285)

Patient Problems Death (1802); Loss of consciousness (2418)

Event Date 01/11/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient was in a rehab facility on a ventilator (not device related).The device exhibited loss of capture in every chamber.The patient was unconscious and it was unknown if there are any symptoms but intrinsic rate has been in the 50s.Upon review of the session record, eri and eos were noted on (b)(6) 2017.Low lead pacing impedance values were also noted during interrogation and suspected it was due to eos status.Device change and further lead testing was planned.It was later reported that the patient expired.It was also reported that the patient had been programmed with a base rate of 80 bpm to prevent frequent torsades arrhythmias.The patient experienced torsades, without pacing and passed away as a result.The device is included in the premature battery depletion with implantable cardioverter defibrillator advisory.

• Brand Name: QUADRA ASSURA CRT-D QUAD RF HV
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6300569
• MDR Text Key: 66482627
• Report Number: 2938836-2017-12808
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Model Number: CD3365-40Q
• Device Lot Number: 4494292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2014
• 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: 1458Q/86, BPP032115; 2088TC/46, CNX017059; 7120Q/58, BNP039139
• Patient Outcome(s): Death
• Patient Age: 41 YR