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

Model Number CD3361-40C

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

Patient Problems Death (1802); Unspecified Infection (1930); Pocket Erosion (2013)

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: 2017865-2020-17382.Related manufacturer reference number: 2017865-2020-17384.Related manufacturer reference number: 2017865-2020-17387.It was reported that the patient presented to the clinic with their implantable cardioverter defibrillator eroding through their skin with signs of infection.The physician explanted the patient's icd and all leads.The patient was stable throughout the procedure.Three days after the explant procedure, the patient passed away due to unknown causes.

• Brand Name: UNIFY ASSURA ICD
• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 10809894
• MDR Text Key: 215311482
• Report Number: 2017865-2020-17381
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• 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: CD3361-40C
• Device Lot Number: S000060507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2018
• 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; ISOFLEX OPTIM; QUICKSITE
• Patient Outcome(s): Death