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

Model Number	CD3257-40Q
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	03/19/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Related manufacturer reference number: 2017865-2019-15618, 2017865-2019-15619.It was reported the patient deceased.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 was unknown.
Additional Manufacturer Narrative
The device was below end-of-service (eos) upon receipt.The device was tested on the bench, and no anomalies were found.

• Brand Name: UNIFY ASSURA ICD
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 9242417
• Report Number: 2017865-2019-15617
• Device Sequence Number: 1934703
• Product Code: NIK
• UDI-Device Identifier: 05414734505635
• UDI-Public: 05414734505635
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2013
• Device Model Number: CD3257-40Q
• Device Catalogue Number: CD3257-40Q
• Device Lot Number: 3697043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 06/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; TENDRIL STS; DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; TENDRIL STS
• Outcome Attributed to Adverse Event: Death
• Patient Age: 68 YR