MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) NEUTRINO NXT VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CDVRA600Q

Device Problems Failure to Charge (1085); Environmental Compatibility Problem (2929); Inappropriate or Unexpected Reset (2959)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/29/2022

Event Type  Injury  

Event Description

It was reported that the patient presented to the emergency room after the implantable cardioverter defibrillator (icd) began beeping.Upon interrogation, it was found that the icd was in backup vvi mode.It was noted that magnetic resonance imaging (mri) was performed without properly programming the device into mri mode prior.The device was restored successfully.Once the device was restored, the physician attempted to perform the capacitor load test.The device again reverted to backup vvi mode.This was attempted multiple times without success.The device was explanted and replaced.The patient was in stable condition.

Manufacturer Narrative

The reported field event of reset was confirmed.Final analysis found the reset was caused by the device being exposed to magnetic resonance imaging (mri) without being programmed for mri use.Interrogation of the device revealed the device was above elective replacement indicator (eri) upon receipt.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.

• Brand Name: NEUTRINO NXT VR
• 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: 15254133
• MDR Text Key: 298194756
• Report Number: 2017865-2022-19735
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: CDVRA600Q
• Device Lot Number: P000132554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2021
• 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): Required Intervention