MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) Unify Assura CRT-D RF HV; Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

Model Number	CD3357-40C
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Code	Dyspnea (1816)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was hospitalized in clinic with an oxygen mask and was not very conscious.The reason for the hospitalization and oxygen mask was unclear.It was noted that the implantable cardioverter defibrillator (icd) could not be interrogated with a programmer using a wand and there was no magnet response.Several attempts to interrogate the icd were unsuccessful.The patient may have been pending an explant procedure, but this could not be conclusively confirmed by the patient's physician.There were no changes in patient condition or reported consequences.
Additional Manufacturer Narrative
Further information was requested but was unavailable at this time.

• Brand Name: Unify Assura CRT-D RF HV
• Common Device Name: Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
• Manufacturer (Section D): Abbott Medical (CRM-Sylmar); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): Abbott Medical (CRM-Sylmar); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 50087370
• Report Number: 2017865-2026-15973
• Device Sequence Number: 18620136
• Product Code: NIK
• UDI-Device Identifier: 05414734508186
• UDI-Public: (01)05414734508186(10)P000197116(17)260228
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/30/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Model Number: CD3357-40C
• Device Catalogue Number: CD3357-40C
• Device Lot Number: P000197116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male