MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY DR, U1.6 DF1 US; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	CD2231-40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented for an implant procedure.It was noted less than a month after implant at a follow up visit that an abscess was present in the wound.The wound was red, swollen but not open.The clinician explanted the pacemaker and lead.A re-implant was to be performed on the opposing side at a later date.The patient was stable.
Additional Manufacturer Narrative
Correction: it was an implantable cardioverter defibrillator (icd) that was explanted, not a pacemaker.
Event or Problem Description
It was reported that the patient presented for an implant procedure.It was noted less than a month after implant at a follow up visit that an abscess was present in the wound.The wound was red, swollen but not open.The clinician explanted the implantable cardioverter defibrillator (icd) and lead.A re-implant was to be performed on the opposing side at a later date.The patient was stable.
Additional Manufacturer Narrative
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.Review of the sterilization records confirmed normal sterilization cycles for the products.The cause of infection could not be determined.
Additional Manufacturer Narrative
Analysis was normal.No anomalies were noted.The implantable cardioverter defibrillator's (icd) battery was above the elective replacement indicator (eri).

• Brand Name: FORTIFY DR, U1.6 DF1 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: 23752364
• Report Number: 2017865-2025-1006847
• Device Sequence Number: 18483107
• Product Code: NVZ
• UDI-Device Identifier: 05414734504379
• UDI-Public: (01)05414734504379(10)A000174996(17)261130
• 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
• 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,Followup,Followup
• Report Date (Section B): 02/18/2026

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 Model Number: CD2231-40
• Device Catalogue Number: CD2231-40
• Device Lot Number: A000174996
• 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: 11/28/2025
• Supplement Date Received by Manufacturer: 12/15/2025; 01/19/2026; 02/17/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 12/19/2025; 01/19/2026; 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2025
• 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: UNKNOWN LEAD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown