MAUDE Adverse Event Report: ABBOTT ENTRANT HF; NO MATCH

Model Number CDHFA300Q

Device Problems Failure to Convert Rhythm (1540); No Apparent Adverse Event (3189)

Patient Problems Arrhythmia (1721); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/12/2024

Event Type  Death  

Event Description

It was reported the patient passed away after undergoing a magnetic resonance imaging (mri) procedure.Prior to the procedure, the device was programmed to mri mode.During the mri procedure, the patient entered ventricular fibrillation (vf).In response, the physician activated emergency vvi, which caused the device to deliver a high voltage (hv) shock.It was reported that the hv shock initially terminated the vf, however, the patient later passed away due to the vf while still in the procedure room.No allegation of malfunction was made against the abbott device.The physician did not allege the abbott device caused or contributed to the patient's death in any way.Additional information was requested but is not yet available.

Event Description

Additional information received indicated the cause of death was due to the irreversible patient condition.The device behaved normally according to its programmed settings.No allegation of malfunction was made against the device, and there was no allegation the device caused or contributed to the patient's passing in any way.

Manufacturer Narrative

Correction: upon review, the pulse generator should not have been submitted as a medical device report (mdr) as the event did not indicate a malfunction caused a serious event.

• 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: 19051127
• MDR Text Key: 339489424
• Report Number: 2017865-2024-37795
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032850
• UDI-Public: (01)05415067032850(10)S000077530(17)220731
• 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: 04/24/2024

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: 07/31/2022
• Device Model Number: CDHFA300Q
• Device Lot Number: S000077530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/05/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/27/2020
• 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
• Patient Outcome(s): Death