MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) UNIFY ASSURA CRT-D RF HV; No Match

Model Number	2088TC/52
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient presented remotely via merlin.Net.Review of transmission revealed that implantable cardioverter defibrillator (icd) delivered inappropriate shock.No intervention was reported.Patient condition was unknown.
Additional Manufacturer Narrative
Additional information was requested but not received.

• Brand Name: UNIFY ASSURA CRT-D RF HV
• Common Device Name: No Match
• 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: 24947212
• Report Number: 2017865-2026-08245
• Device Sequence Number: 10084663
• Product Code: NVN
• UDI-Device Identifier: 05414734508186
• UDI-Public: (01)05414734508186(10)A000118257(17)231130
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P960013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/21/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 2088TC/52
• Device Lot Number: A000118257
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: QUICKFLEX; TENDRIL; TENDRIL
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female