MAUDE Adverse Event Report: ABBOTT GALLANT DR; NO MATCH

Model Number CDDRA500Q

Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395); Over-Sensing (1438); Capturing Problem (2891); Migration (4003)

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

Event Date 12/27/2023

Event Type  Injury  

Event Description

Related manufacturer report number: 2017865-2024-00861.It was reported that far field p-wave oversensing and an increase in capture threshold was observed on the right ventricular (rv) channel.Abbott technical support was contacted and confirmed the reported events.An x-ray was performed and revealed that the device migrated which resulted in an increase in lead tension.This is the suspected cause of the electrical anomalies.No intervention has been performed at this time to resolve the event.The patient was in stable condition and will continue to be monitored.

Event Description

Additional information received indicated the device was explanted and replaced to resolve the event.The patient was in stable condition.During the replacement procedure, the set screw was unable to be tightened to the device.

Manufacturer Narrative

The reported field event of set screw connection anomaly was confirmed.Review of the electrocardiograms confirmed the reported event of oversensing.However, the cause of oversensing was determined to be due to external non-device related factors.The device behaved as expected and according to its programmed settings.Analysis revealed the right ventricular set screw was backed out of its connector block as a result of unscrewing the setscrew too far.The setscrew was also stripped and contained septum material inside the hex cavity.The backed-out setscrew prevented full insertion of the torque driver and was the cause of the reported event.The set screw anomaly was consistent with having occurred during the procedure.

• 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: 18493900
• MDR Text Key: 332674852
• Report Number: 2017865-2024-00860
• 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,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDDRA500Q
• Device Lot Number: P000173006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2023
• 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): Other; Required Intervention