MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) UNIFY CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3231-40

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Death (1802); Therapeutic Effects, Unexpected (2099); Heart Failure (2206)

Event Date 04/04/2018

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 the patient expired.The cause of death was cardiac non-arrhythmia.Patient arrived at the clinic after receiving a shock from the device.Patient had acute chronic heart failure.No further information is available at this time.

Event Description

New information received indicated that the patient expired due to congestive heart failure.No allegation from a health professional that suggest the death was related to the device.Patient was last seen in-clinic on (b)(6) 2018.There was no further information if the device delivered inappropriate or appropriate shock to the patient.Patient was provided with comfort measures.

• Brand Name: UNIFY CRT-D
• 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: 7521140
• MDR Text Key: 108479590
• Report Number: 2938836-2018-04138
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• 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
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2011
• Device Model Number: CD3231-40
• Device Catalogue Number: CD3231-40
• Device Lot Number: 3151416
• Other Device ID Number: 05414734504362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2010
• 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: 0185-64 (B)(4); 1056T/86 (B)(4); 2088TC/52 (B)(4)
• Patient Outcome(s): Death
• Patient Age: 56 YR