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

Model Number CDHFA600Q

Device Problems Failure to Interrogate (1332); Wireless Communication Problem (3283)

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

Event Date 05/23/2023

Event Type  malfunction  

Event Description

It was reported that the patient exhibited difficulty in pairing their implantable cardioverter defibrillator (icd) to the merlin app.Upon further investigation, it was found that the icd exhibited loss of bluetooth telemetry functionality.No changes were reported.There were no patient consequences.

Event Description

New information received notes the patient was brought into clinic and the device was in lockout mode.This alert was cleared, and the bluetooth was successfully paired.There were no patient consequences.

Manufacturer Narrative

The reported event of ble unavailable was resolved by interrogating the device using a merlin programmer, this is indicative of a ble lockout which is per device design.

• Brand Name: NEUTRINO NXT HF
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 17127381
• MDR Text Key: 317208096
• Report Number: 2017865-2023-23187
• 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,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/11/2023

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: CDHFA600Q
• Device Lot Number: P000150879
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 06/14/2023
• Supplement Dates Manufacturer Received: 06/23/2023; 08/08/2023
• Supplement Dates FDA Received: 07/10/2023; 08/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2022
• 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