MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) Gallant¿ VR; Implantable Cardioverter Defibrillator (Non-Crt)

Model Number	CDVRA500T
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's implantable cardioverter defibrillator (icd) exhibited low pacing output.The physician elected to explant and replace the icd.The patient condition was not known.
Additional Manufacturer Narrative
Reported complaint of low pacing output issues was not confirmed.The device was received in normal range of operation.Analysis of device image was performed and no anomalies were noted.Further electrical testing was performed, including impedance and output testing, and no issues were noted.Longevity assessment found the device was operating above elective replacement indicator (eri) level and within expected longevity.

• Brand Name: Gallant¿ VR
• Common Device Name: Implantable Cardioverter Defibrillator (Non-Crt)
• Manufacturer (Section D): Abbott Medical (CRM-Sylmar); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): Abbott Medical (CRM-Sylmar); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 50181236
• Report Number: 2017865-2026-16613
• Device Sequence Number: 8281725
• Product Code: LWS
• UDI-Device Identifier: 05415067049421
• UDI-Public: (01)05415067049421(10)S000098248(17)260831
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

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: 08/31/2026
• Device Model Number: CDVRA500T
• Device Catalogue Number: CDVRA500T
• Device Lot Number: S000098248
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/20/2026
• 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: 07/20/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2024
• 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: Durata
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female