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

Model Number	CD1231-40
Medical Device Problem Codes	Premature Discharge of Battery (1057); Failure to Interrogate (1332); No Pacing (3268)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	06/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented to the hospital with a complaint of dizziness.The implantable cardioverter defibrillator (icd) was unable to be interrogated and the was no observable pacing output.Premature battery depletion was suspected.The device was explanted and replaced.The patient was stable.
Additional Manufacturer Narrative
Correction: the 5-day box was erroneously selected in section g6 - type of report in the initial report.The boxes that should have been selected are initial and 30-day.
Additional Manufacturer Narrative
The reported events of no output, failure to interrogate and premature discharge of battery were confirmed.The device was received with no telemetry communication and no output.The device was cut open to enable further testing and the battery was found depleted.Hybrid circuitry was tested by connecting to an external power source.Test results indicated high current drain, isolated to an integrated circuits (ic) anomaly, which depleted the battery and resulted in the reported events.

• Brand Name: FORTIFY VR, 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: 22408427
• Report Number: 2017865-2025-91430
• Device Sequence Number: 9673464
• Product Code: NVZ
• UDI-Device Identifier: 05414734504355
• UDI-Public: (01)05414734504355(10)A000122912(17)230930
• 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: 2022
• 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
• Report Date (Section B): 03/18/2026

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 Expiration Date: 09/30/2023
• Device Model Number: CD1231-40
• Device Catalogue Number: CD1231-40
• Device Lot Number: A000122912
• 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): Five-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 07/18/2025; 03/05/2026
• Initial Report FDA Received Date: 07/06/2025
• Supplement Report FDA Received Date: 07/18/2025; 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2022
• 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: Required Intervention
• Patient Sex: Unknown