MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY VR, U1.6 SJ4 US; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	CD1231-40Q
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Unspecified Infection (1930); Pocket Erosion (2013)
Date of Event	12/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented to hospital with redness, discharge, infection and erosion at device pocket.The wound has not healed properly.The infection was not associated with any abbott product and/or procedure.The high voltage device was explanted.The patient was in stable condition throughout the procedure.
Additional Manufacturer Narrative
Correction: the b5 and h6 sections have been updated, and the erosion code has been removed.
Event or Problem Description
It was reported that the patient presented to hospital with redness, discharge and infection at device pocket.The wound has not healed properly.The infection was not associated with any abbott product and/or procedure.The high voltage device was explanted.The patient was in stable condition throughout 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.

• Brand Name: FORTIFY VR, U1.6 SJ4 US
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• 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: 24000309
• Report Number: 2017865-2026-00552
• Device Sequence Number: 18741473
• Product Code: NVZ
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/22/2026

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: 10/31/2025
• Device Model Number: CD1231-40Q
• Device Catalogue Number: CD1231-40Q
• Device Lot Number: A000158171
• 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: 12/26/2025
• Supplement Date Received by Manufacturer: 01/14/2026; 04/06/2026; 06/16/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 01/15/2026; 04/06/2026; 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown