MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) Gallant HF; Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

Model Number	CDHFA500Q
Medical Device Problem Codes	High impedance (1291); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a device exchange procedure on (b)(6) 2026.After the procedure, the patient was monitored remotely via merlin.Net.Review of the transmission revealed that the right ventricular (rv) lead exhibited high, out-of-range defibrillation impedance, and the left ventricular (lv) lead exhibited high, out-of-range pacing impedance.Diagnostic imaging confirmed that the leads were not properly secured in the set screws of the implantable cardioverter defibrillator (icd).During the lead revision procedure, the rv lead was found to be disconnected from the icd, and the lv lead was also found to be loose.The rv and lv leads were cleaned and secured by tightening the set screws, and the impedance values returned to the normal range.The patient remained stable throughout the procedure.

• Brand Name: Gallant HF
• Common Device Name: Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
• 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: 50927573
• Report Number: 2017865-2026-20566
• Device Sequence Number: 18824997
• Product Code: NIK
• UDI-Device Identifier: 05415067032010
• UDI-Public: (01)05415067032010(10)A000183194(17)271231
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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 Model Number: CDHFA500Q
• Device Catalogue Number: CDHFA500Q
• Device Lot Number: A000183194
• 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: 09/08/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2026
• 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: MRI Condtendril
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Race: White