MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) NEUTRINO NXT DR; No Match

Model Number CDDRA600Q

Device Problems Failure to Deliver Shock/Stimulation (1133); Incorrect Measurement (1383); Failure to Convert Rhythm (1540); Incorrect Interpretation of Signal (1543)

Patient Problem Dizziness (2194)

Event Date 10/01/2023

Event Type  malfunction  

Event Description

It was reported that the patient had ventricular tachycardia (vt) but the implantable cardioverter defibrillator (icd) called it supraventricular tachycardia due to a gradual onset.The majority of the scores did not match at zero while four of the last twelve beats matched above 90.The physician was concerned the patient did not get treatment as the patient started to feel dizzy and unwell.Symptoms were correlated to device episodes which showed ventricular tachycardia (vt) but the episode ended as the rhythm slowed down.Programming changes to adress the morphology vector and supraventicular discrimination was completed.Scoring of morphology template was matching on both vectors.The patient was to continue with a follow up in clinic.There were no patient consequences.

• Brand Name: NEUTRINO NXT DR
• 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: 18004271
• MDR Text Key: 326498885
• Report Number: 2017865-2023-50612
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDDRA600Q
• Device Lot Number: P000167638
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/05/2023
• Initial Date FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2023
• 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