MAUDE Adverse Event Report: ABBOTT NEUTRINO NXT VR; NO MATCH

Model Number CDVRA600Q

Device Problem Failure to Interrogate (1332)

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

Event Type  malfunction  

Event Description

It was reported that a bluetooth low energy (ble) telemetry anomaly occurred on the device which caused the remote monitoring smartphone application to be unable to pair with the device.Abbott technical support was contacted, and a ble telemetry reset was performed on the device, however, the anomaly persisted.No intervention was performed at this time.The patient was stable and will continue to be monitored.

Manufacturer Narrative

B3 - event date is estimated to be in apr 2024.D6a - implant date is estimated to be in (b)(6) 2024.

• Brand Name: NEUTRINO NXT VR
• Type of Device: NO MATCH
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 19192372
• MDR Text Key: 341157843
• Report Number: 2017865-2024-39842
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067034373
• UDI-Public: (01)05415067034373(10)P000194996(17)260228
• Combination Product (y/n): N
• Reporter Country Code: SI
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/17/2024

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 Model Number: CDVRA600Q
• Device Lot Number: P000194996
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/12/2024
• Initial Date FDA Received: 04/26/2024
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/29/2024
• 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