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 Codes	Break (1069); Inappropriate or Unexpected Reset (2959)
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 the patient's implantable cardioverter defibrillator was found in backup vvi mode.High voltage therapies were not available while the device was in backup mode.The device was unable to be restored.The device was removed and replaced on (b)(6) 2024.The patient's condition was good.
Event or Problem Description
Information received on (b)(6) 2024, indicates that the operator thought that the backup vvi mode was triggered due to potential defibrillator damage or quality issue.
Additional Manufacturer Narrative
Correction: d6b.
Additional Manufacturer Narrative
Correction: h6 - medical device problem code.
Additional Manufacturer Narrative
The reported field event of unexpected reset was confirmed by analysis.Upon receipt, the device was found to be in bvvi mode.A review of the device image could not confirm the cause of the por reset.Memory testing was performed, and no anomalies were found.The cause of the por reset remains undetermined.

• 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: 20736636
• Report Number: 2017865-2024-70470
• Device Sequence Number: 8755639
• Product Code: NVZ
• UDI-Device Identifier: 05414734504379
• UDI-Public: (01)05414734504379(10)A000107542(17)220930
• 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: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/13/2025

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: 09/30/2022
• Device Model Number: CD2231-40
• Device Lot Number: A000107542
• 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: 11/08/2024
• Supplement Date Received by Manufacturer: 11/20/2024; 11/20/2024; 03/12/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 11/26/2024; 11/27/2024; 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown