MAUDE Adverse Event Report: ABBOTT ENTRANT DR; NO MATCH

Model Number CDDRA300Q

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

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

Event Date 04/12/2024

Event Type  malfunction  

Event Description

It was reported that oversensing and loss of capture were observed on the device.Abbott technical support was contacted and recommended reprogramming, which was anticipated to resolve the event.The patient was stable and there were no adverse consequences.

Event Description

It was reported that oversensing and loss of capture were observed on the device.Abbott technical support was contacted and recommended reprogramming, which was performed to resolve the event.The patient was stable and will continue to be monitored; there were no adverse consequences.

• Brand Name: ENTRANT 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: 19217466
• MDR Text Key: 341438011
• Report Number: 2017865-2024-40110
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032843
• UDI-Public: (01)05415067032843(10)S000088271(17)241031
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDDRA300Q
• Device Lot Number: S000088271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/17/2022
• 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