MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUADRA ASSURA (DDQP+); IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3265-40

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

Patient Problems Congestive Heart Failure (1783); Death (1802); Renal Failure (2041); Ventricular Tachycardia (2132)

Event Date 11/22/2016

Event Type  Death  

Manufacturer Narrative

Interrogation of the device revealed it was above eri when received.Based on this information, the device was found to communicate appropriately with a merlin programmer and has not reached the elective replacement indicator (eri).

Event Description

It was reported that the patient expired.There is no known allegation from a health professional that suggests the death was related to the device.It was reported that the cause of death is unknown.On (b)(6) 2013, the patient presented in af and cardioversion restored patient to sinus rhythm.No further information is available at this time.

Event Description

New information received states that the patient was presented for clinic visit on (b)(6) 2016.The patient was noted to be in overt congestive heart failure (chf) without significant sustained arrhythmias.The patient was seen again for chf exacerbation on (b)(6) 2016 by cardiology rn and patient was advised to present to the emergency room and was ultimately admitted to the intensive care unit.During the hospitalization, patient was found to have decompensated chf, acute renal failure and was supported with intravenous positive inotropic agents.A slow ventricular tachycardia (vt) at rates between 100-120 bpm was also observed.The patient was treated with medications and the device was programmed to treat slow vt.On (b)(6) 2016, the device successfully gave therapy to rescue the patient from slow but hemodynamically significant ventricular tachycardia.Despite intensive critical care, it was reported that the patient continued to decline clinically.The patient opted to enter hospice and the device tachy therapies were turned off and discharged to hospice on (b)(6) 2016.Patient expired from progressive chf on (b)(6) 2016.

• Brand Name: QUADRA ASSURA (DDQP+)
• 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: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7298592
• MDR Text Key: 100997431
• Report Number: 2938836-2018-01604
• 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,Followup,Followup,Followup
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: CD3265-40
• Device Catalogue Number: CD3265-40
• Device Lot Number: 4226806
• Other Device ID Number: 05414734505666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2013
• 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
• Patient Outcome(s): Death
• Patient Age: 79 YR