MAUDE Adverse Event Report: ABBOTT GALLANT DR; NO MATCH

Model Number CDDRA500Q

Device Problems Failure to Capture (1081); Over-Sensing (1438)

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

Event Date 02/20/2024

Event Type  malfunction  

Event Description

Related manufacturer report number 2017865-2024-35382.It was reported that during a remote follow up, right ventricular loss of capture and oversensing were noted.Abbott technical support was contacted, however, no intervention has been performed at this time.The patient was in stable condition and will continue to be monitored.

Event Description

Related manufacturer report number 2017865-2024-35382.It was reported that during a remote follow up, right ventricular loss of capture was noted.Abbott technical support was contacted, however, no intervention has been performed at this time.The patient was in stable condition and will continue to be monitored.

• 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: 18935743
• MDR Text Key: 338067415
• Report Number: 2017865-2024-35383
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032003
• UDI-Public: 05415067032003
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 03/27/2024

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 Operator: Health Professional
• Device Model Number: CDDRA500Q
• Device Lot Number: P000178744
• 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: 03/19/2024
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2023
• 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