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

Model Number CDDRA600Q

Device Problems Failure to Charge (1085); Incorrect Measurement (1383)

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

Event Date 02/09/2024

Event Type  Injury  

Event Description

It was reported that a charge time out alert was received by the device.Technical support was contacted and the charge time out alert was suspected to be due to the depleted battery of the device.It is unknown if the depletion was suspected to be normal or due to premature depletion.Furthermore, the longevity of the device was inaccurate, but upon investigation, was due to normal behavior after the amount of device charging that had occurred.The device was explanted and replaced to resolve the event.The patient was stable and will continue to be monitored.

Manufacturer Narrative

The reported event of extended charge time was confirmed by reviewing the data in the device image.However, the extended charge time was due to excessive number of high voltage (hv) charges within a short timeframe that didn¿t leave enough time for the capacitors to properly charge and discharge.Interrogation of the device revealed the device was above elective replacement indicator (eri) when received.Telemetry, impedance, sensing, pacing and hv output functions of the device were tested and found to be normal.

• Brand Name: NEUTRINO NXT DR
• 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: 18766697
• MDR Text Key: 336103263
• Report Number: 2017865-2024-33046
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDDRA600Q
• Device Lot Number: P000180440
• 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: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2023
• 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
• Patient Outcome(s): Required Intervention