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	Premature Discharge of Battery (1057); Delayed Charge Time (2586)
Health Effect - Clinical Codes	Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implantable cardioverter defibrillator (icd) exhibited delayed charge time.As a resolution programming changes were made but the issue persisted.The patient condition 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.
Event or Problem Description
New information received indicated that the implantable cardioverter defibrillator (icd) exhibited premature battery depletion.The physician explanted the icd.
Event or Problem Description
New information received indicated that the patient experienced discomfort such as pain, fear, and anxiety due to the explant procedure of the icd.
Additional Manufacturer Narrative
Reported events of slow charging and premature discharge of battery were confirmed.The device was in backup vvi mode upon receipt.Analysis of device image indicated the device went into backup vvi mode due to reset error caused by battery depletion.A longevity calculation was performed and found the battery depletion was premature.The device was cut open and battery voltage was found at end of life (eol) level.Electrical testing revealed no high current drain sources.Battery analysis by the manufacturer found lithium cluster formation within the cell but at the time of analysis the clusters did not appear to be in a location or size that would be sufficient to cause an internal short of the battery.From these analyses, in the absence of high current draw, it is probable that the premature battery depletion and slow charging was caused by a lithium cluster induced short circuit.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.

• 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: 22822219
• Report Number: 2017865-2025-97533
• Device Sequence Number: 21151035
• Product Code: NVZ
• UDI-Device Identifier: 05414734504386
• UDI-Public: (01)05414734504386(10)A000164510(17)260331
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/01/2026

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: 03/31/2026
• Device Model Number: CD2231-40Q
• Device Catalogue Number: CD2231-40Q
• Device Lot Number: A000164510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 08/20/2025; 11/05/2025; 11/12/2025; 11/24/2025; 05/29/2026
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 08/29/2025; 11/06/2025; 11/13/2025; 11/24/2025; 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2024
• 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