MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) GALLANT ¿ HF; NO MATCH

Model Number	CDHFA500T
Medical Device Problem Codes	High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented remotely.A remote transmission showed that the patient's implantable cardioverter defibrillator (icd) exhibited high, out-of-range defibrillation impedance.A diagnostic anomaly was also noted that the defibrillation impedance out of range alert was missing and that the lifetime ranges were absent from testing results.No intervention was performed.The patient had no adverse consequences due to the event.
Additional Manufacturer Narrative
The reported event of out-of-range impedance values was confirmed.Based on the information provided, it was determined that the impedance values have been out of range since implant, indicating an issue with the right ventricular lead.No device malfunction was observed.

• Brand Name: GALLANT ¿ HF
• Common Device Name: NO MATCH
• 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: 24675123
• Report Number: 2017865-2026-06047
• Device Sequence Number: 21422510
• Product Code: NIK
• UDI-Device Identifier: 05415067049520
• UDI-Public: (01)05415067049520(10)S000094423(17)260331
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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 Expiration Date: 03/31/2026
• Device Model Number: CDHFA500T
• Device Catalogue Number: CDHFA500T
• Device Lot Number: S000094423
• 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: 03/05/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2024
• 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: QUARTET; RIGHT VENTRICULAR LEAD; TENDRIL
• Patient Age: 75 YR
• Patient Sex: Male