MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GALLANT¿ DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	CDDRA500T
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an implant procedure, the implantable cardioverter defibrillator's set screw was too loose and unable to be tightened.The device was successfully replaced to complete the procedure.No adverse patient consequences were reported.
Additional Manufacturer Narrative
The reported event of set screw too loose was confirmed.The device voltage was above elective replacement indicator (eri) upon receipt.Assessment of total projected longevity was performed, and the device was found to have appropriate remaining longevity.Analysis revealed setscrew heavily stripped, consistent with occurring during procedure.Electrical and mechanical tests performed including lead impedance and output verification did not identify any functional issues.

• Brand Name: GALLANT¿ DR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: 23696190
• Report Number: 2017865-2025-1006379
• Device Sequence Number: 10288316
• Product Code: LWS
• UDI-Device Identifier: 05415067049476
• UDI-Public: (01)05415067049476(10)S000104424(17)270430
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CDDRA500T
• Device Catalogue Number: CDDRA500T
• Device Lot Number: S000104424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2025
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2025
• 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: DURATA; RIGHT ATRIAL LEAD
• Patient Age: 75 YR
• Patient Sex: Male