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 Code	Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event of inappropriate or unexpected reset 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 of the device image indicated reset error occurred, consistent with time of event device having been dropped in the field; however, the error condition is no longer present.User manual states sterility, integrity, or function cannot be guaranteed upon device being dropped.Further analysis of the device¿s telemetry, lead impedance, pacing, sensing, and high voltage charging were found to be normal.The backup operation could not be reproduced during analysis.
Additional Manufacturer Narrative
Correction: h6: health effect - impact code should have been "4632 - prolonged surgery.".
Event or Problem Description
It was reported that the implantable cardioverter defibrillator (icd) was found to be in back-up operation mode before implanting.

• 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: 50950891
• Report Number: 2017865-2026-20747
• Device Sequence Number: 9499762
• Product Code: NIK
• UDI-Device Identifier: 05415067032010
• UDI-Public: (01)05415067032010(10)A000190334(17)280630
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/30/2026

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 Model Number: CDHFA500Q
• Device Catalogue Number: CDHFA500Q
• Device Lot Number: A000190334
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/17/2026
• 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: 09/10/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2026
• 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
• Patient Sex: Unknown