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

Model Number CD3357-40C

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

Patient Problems Arrhythmia (1721); Death (1802); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Pocket Erosion (2013)

Event Date 10/28/2019

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

Related manufacturer reference number: 2017865-2019-15996.Related manufacturer reference number: 2017865-2019-15997.Related manufacturer reference number: 2017865-2019-15999.It was reported that a pacer dependent patient presented for a routine generator change on (b)(6) 2019.On (b)(6) 2019, the patient presented for a follow-up in clinic when it was noted that the patient's device pocket had eroded and it was concluded that the patient had developed an infection as a result.During the explant procedure on (b)(6) 2019, after the leads were removed, the patient experienced a drop in blood pressure and went into asystole.The patient was coded before being declared deceased.The physician does not allege that the patient's death was related to any of the devices but it is unknown if the procedure may have contributed.

• Brand Name: UNIFY ASSURA CRT-D 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: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 9281662
• MDR Text Key: 165133778
• Report Number: 2017865-2019-15995
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508186
• UDI-Public: 05414734508186
• 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: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: CD3357-40C
• Device Catalogue Number: CD3357-40C
• Device Lot Number: A000078923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 11/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2019
• 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: DURATA STS OPTIM ACTIVE FIXATION; RIATA ST PASSIVE FIXATION; TENDRIL SDX LEAD
• Patient Outcome(s): Death
• Patient Age: 59 YR