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 Unspecified Infection (1930); Respiratory Failure (2484); Heart Failure/Congestive Heart Failure (4446)

Event Date 12/06/2020

Event Type  Death  

Manufacturer Narrative

Further information was requested but not received.

Event Description

Related manufacturer reference number: 2017865-2020-08623; related manufacturer reference number: 2017865-2020-08624.It was reported that the patient has deceased.There is no known allegation from a health care professional that suggests the death was device related.The cause of death was cardiopulmonary arrest, multisystem organ failure, and septic shock.No additional information was available.

Manufacturer Narrative

The device was returned for evaluation after the patient was reported to have expired.Analysis was normal.No anomalies were found.Correction d9 - return date should have been jan 29, 2021 not feb 3, 2021 as previously reported.

• 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
• MDR Report Key: 11335824
• MDR Text Key: 232143975
• Report Number: 2017865-2021-08618
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508186
• UDI-Public: 05414734508186
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: CD3357-40C
• Device Catalogue Number: CD3357-40C
• Device Lot Number: A000055628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1158T/86 QUICKFLEXLEADS_U_US; 1788TC/52 PKG/STER US,TENDRIL SDX; 1158T/86 QUICKFLEXLEADS_U_US; 1788TC/52 PKG/STER US,TENDRIL SDX
• Patient Outcome(s): Death
• Patient Age: 81 YR