MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) Gallant Bipolar DF1 HF; Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

Model Number	CDHFA500B
Medical Device Problem Code	Migration (4003)
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 exhibited twiddler's syndrome causing the right atrial (ra) and right ventricular (rv) leads to become dislodged.The ra and rv lead exhibited low impedance and loss of capture.An x-ray was performed, and dislodgement of the ra and rv lead were confirmed.Additionally, the implantable cardioverter defibrillator (icd) migrated due to the patient's twiddler's syndrome.The physician explanted and replaced the ra and rv lead.During the procedure, a replacement rv lead was not used due to difficulty obtaining capture.On (b)(6) 2026, during the procedure, the physician also repositioned the icd.There were no patient consequences reported.

• Brand Name: Gallant Bipolar DF1 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: 50378219
• Report Number: 2017865-2026-17660
• Device Sequence Number: 12162304
• Product Code: NIK
• UDI-Device Identifier: 05415067050090
• UDI-Public: (01)05415067050090
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/21/2026

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: CDHFA500B
• Device Catalogue Number: CDHFA500B
• Device Lot Number: A000174386
• 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: Not provided
• Initial Report FDA Received Date: 08/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2025
• 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: Amplatzer Amulet Occluder.; RV Lead.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male