MAUDE Adverse Event Report: ABBOTT GALLANT DR; NO MATCH

Model Number CDDRA500Q

Device Problem Interrogation Problem (4017)

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

Event Date 09/14/2023

Event Type  malfunction  

Event Description

During an in clinic follow up, when interrogating the device using bluetooth (ble) telemetry it was observed the interrogation time was long for retrieving episodes when there were no episodes to be reviewed.The patient was stable and will continue being monitored.

Manufacturer Narrative

It was reported that the device took longer than expected to be interrogated, despite there being no episodes to review.Based on the limited information present in merlin navigation logs, it was confirmed that episodal diagnostics did not have any entry.There were more than 25 segm¿s that were present, although no new episodes.Programmer will read those saved segm and waveform data and present to the user in episode workspace.It is suspected that the episode data was cleared, but segms were not, resulting in the longer than normal interrogation.

• Brand Name: GALLANT 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: 17865184
• MDR Text Key: 324885061
• Report Number: 2017865-2023-47643
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032003
• UDI-Public: 05415067032003
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDDRA500Q
• Device Lot Number: P000148397
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2022
• 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