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

Model Number CD3231-40

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

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

The investigation results will be provided in the final report.

Event Description

It was reported that the patient deceased.There is no known allegation from a health professional that suggests the death was related to the device.

Event Description

Related manufacturer reference number:2017865-2020-07412.Related manufacturer reference number:2017865-2020-07413.Related manufacturer reference number:2017865-2020-07414.It was reported that the patient deceased.There is no known allegation from a health professional that suggests the death was related to the device.

Manufacturer Narrative

Analysis was normal.No anomalies were found.

• Brand Name: UNIFY CRT-D
• 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: 10136208
• MDR Text Key: 194591367
• Report Number: 2017865-2020-07340
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734504362
• UDI-Public: 05414734504362
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/27/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2012
• Device Model Number: CD3231-40
• Device Catalogue Number: CD3231-40
• Device Lot Number: 3306513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/21/2020
• Initial Date FDA Received: 06/09/2020
• Supplement Dates Manufacturer Received: 05/21/2020; 08/10/2020
• Supplement Dates FDA Received: 06/10/2020; 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: QUICKSITE LV; RIATA ST ACTIVE FIXATION; TENDRIL SDX LEAD
• Patient Outcome(s): Death
• Patient Age: 89 YR