MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY DR, U1.6 SJ4 US; Pulse generator, permanent, implantable

Model Number	CD2231-40Q
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during in clinic follow up that the implantable cardioverter defibrillator was in backup mode and that multiple shocks were seen to be delivered the night before, but their appropriateness was unable to be verified.It was believed that electromagnetic interference from a nearby electrical substation may have contributed to the device entering backup mode.The device was successfully restored back to normal function.The patient was stable.

• Brand Name: FORTIFY DR, 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: 22012053
• Report Number: 2017865-2025-53602
• Device Sequence Number: 17441422
• Product Code: NVZ
• UDI-Device Identifier: 05414734504386
• UDI-Public: (01)05414734504386(10)A000121766(17)230831
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/13/2025

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: 08/31/2023
• Device Model Number: CD2231-40Q
• Device Catalogue Number: CD2231-40Q
• Device Lot Number: A000121766
• Was Device Available for Evaluation?: No
• 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: 05/02/2025
• Initial Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2022
• 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: Other
• Patient Sex: Unknown