MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY CRT-D; NO MATCH

Model Number	CD3231-40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930)
Date of Event	07/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was experiencing repeated fever for the past two years since the implantable cardiac defibrillator (icd) implant.The physician was unsure if the infection was related to abbott device and procedure.The icd, right ventricular (rv) lead, left ventricular (lv) lead and right atrial (ra) leads were explanted and not replaced.The patient is recovering following the procedure.
Additional Manufacturer Narrative
The sterilization records were reviewed and no evidence of abnormal sterilization cycle was found.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Additional Manufacturer Narrative
The reported event was infection.The device was received with normal pacing outputs, telemetry, and normal battery voltage levels.During analysis, a failure event was observed which was unrelated to the reported event.Final analysis detected an indication of possible high-voltage circuit damage.Further analysis of the hybrid circuitry identified a shorted component, consistent with damage caused by the lead short that occurred when the leads were cut during the explant procedure.A device history record (dhr) review was performed, and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.

• Brand Name: UNIFY CRT-D
• Common Device Name: NO MATCH
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 22628441
• Report Number: 2017865-2025-96002
• Device Sequence Number: 12756992
• Product Code: NIK
• UDI-Device Identifier: 05414734504362
• UDI-Public: (01)05414734504362(10)A000137277(17)240731
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: CD3231-40
• Device Catalogue Number: CD3231-40
• Device Lot Number: A000137277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/18/2025
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown