MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY ASSURA ICD; No Match

Model Number CD3361-40QC

Device Problems Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Arrhythmia (1721)

Event Date 04/06/2024

Event Type  Injury  

Manufacturer Narrative

Further information was requested but not received.

Event Description

It was reported that the patient for follow up.An interrogation of the implantable cardioverter defibrillator revealed over-sensing that caused the device misclassify tachycardia episodes.This caused an episode of ventricular tachycardia (vt) to progress into ventricular fibrillation (vf) due to anti-tachycardia pacing that accelerated the rhythm.No patient symptoms or interventions were reported.Further information was requested but not received.

• Brand Name: UNIFY ASSURA ICD
• Type of Device: No Match
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 19188098
• MDR Text Key: 341114200
• Report Number: 2017865-2024-39692
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508247
• UDI-Public: (01)05414734508247(10)P000118526(17)230331
• 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: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: CD3361-40QC
• Device Lot Number: P000118526
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/05/2021
• 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): Other