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

Model Number CD3361-40QC

Device Problems Failure to Capture (1081); Failure to Interrogate (1332)

Patient Problems Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914); Syncope/Fainting (4411)

Event Date 07/26/2021

Event Type  Injury  

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

It was reported that the patient presented in the emergency room after experiencing bradycardia, a syncopal episode, low blood pressure and fall.Upon attempted interrogation of the implantable cardioverter-defibrillator (icd), it was observed that the icd could not be interrogated by the programmer or by magnet.The icd was explanted and replaced.The patient was discharged in stable condition.

Manufacturer Narrative

The reported event of failure to interrogate was confirmed.Analysis of the device revealed the device was below the end of life (eol) battery voltage when received.A longevity calculation was performed and found the battery depletion was premature.The cause of the communication failure was due to low battery voltage as a result of a premature battery depletion.The battery was sent to its manufacturing site for analysis, and it was determined the premature depletion was due to an internal battery anomaly.The cause of the premature depletion is an internal battery anomaly.

• 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: 12337696
• MDR Text Key: 267103038
• Report Number: 2017865-2021-28250
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: IR
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: CD3361-40QC
• Device Lot Number: A000094909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/28/2021
• Initial Date FDA Received: 08/18/2021
• Supplement Dates Manufacturer Received: 11/17/2021; 01/05/2023
• Supplement Dates FDA Received: 11/17/2021; 01/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2020
• 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
• Patient Outcome(s): Required Intervention; Other