MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GALLANT¿ VR; Implantable cardioverter defibrillator (non-CRT)

Model Number	CDVRA500T
Medical Device Problem Codes	Incorrect Interpretation of Signal (1543); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient presented remotely via merlin.Net.Review of the transmission revealed inappropriate anti-tachycardia pacing therapy delivered for supraventricular tachycardia on their implantable cardioverter defibrillator (icd).No changes or interventions were reported.The patient condition was not known.

• Brand Name: GALLANT¿ VR
• 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: 22519871
• Report Number: 2017865-2025-93226
• Device Sequence Number: 7951377
• Product Code: LWS
• UDI-Device Identifier: 05415067049421
• UDI-Public: (01)05415067049421(10)S000096063(17)260430
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/16/2025

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: 04/30/2026
• Device Model Number: CDVRA500T
• Device Catalogue Number: CDVRA500T
• Device Lot Number: S000096063
• 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: 06/26/2025
• Initial Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MEDTRONIC RV LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Female