MAUDE Adverse Event Report: ABBOTT ENTRANT HF; NO MATCH

Model Number CDHFA300Q

Device Problems Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)

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

Event Date 01/05/2024

Event Type  Injury  

Event Description

It was reported that noise resulting in oversensing and inappropriate antitachycardia pacing was observed on the device.Abbott technical support was contacted and confirmed the reported events.The device was explanted and replaced to resolve the event and the patient was in stable condition.

Manufacturer Narrative

The reported event of oversensing noise and inappropriate therapy were confirmed.Device image was reviewed by technical services.Noise was due to lead integrity issue.Oversensing was due to lead noise and inappropriate therapy was due to oversensing of the noise.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.No device anomaly was observed.

• Brand Name: ENTRANT HF
• 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: 18804064
• MDR Text Key: 336505937
• Report Number: 2017865-2024-33717
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: CDHFA300Q
• Device Lot Number: S000077821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2020
• 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