MAUDE Adverse Event Report: ABBOTT GALLANT DR; NO MATCH

Model Number CDDRA500Q

Device Problems Failure to Deliver Shock/Stimulation (1133); Incorrect Interpretation of Signal (1543)

Patient Problem Arrhythmia (1721)

Event Date 04/05/2024

Event Type  Injury  

Event Description

During an in-clinic follow-up, an episode of ventricular tachycardia (vt) was noted on the device which was incorrectly interpreted as a supraventricular tachycardia (svt) and resulted in delayed therapy.The device was later able to correctly interpret the arrhythmia and delivered appropriate therapy.Abbott technical support was contacted and noted the device behaved appropriately according to its programmed settings.New programming parameters were provided in order to avoid any future delayed therapy.Reprogramming is anticipated, however, no intervention was performed at this time.The patient was stable and will continue to be monitored.

Event Description

Additional information received indicated the device was later reprogrammed to resolve the event.The patient was in stable condition.

• 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: 19144054
• MDR Text Key: 340603619
• Report Number: 2017865-2024-39135
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032003
• UDI-Public: (01)05415067032003(10)P000122238(17)230430
• 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: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: CDDRA500Q
• Device Lot Number: P000122238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Supplement Dates Manufacturer Received: 04/19/2024
• Supplement Dates FDA Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/26/2021
• 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): Other