MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GALLANT BIPOLAR DF1 HF; NO MATCH

Model Number	CDHFA500B
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented for a scheduled implantable cardioverter defibrillator (icd) implantation procedure.During the procedure, it was observed that the lead could not be properly placed in the header of icd due to a set screw issue.As a result, the icd was not implanted and replaced with new icd.The patient's condition remained stable.
Additional Manufacturer Narrative
Reported event of loose or intermittent connection was confirmed.The device was above elective replacement indicator (eri) upon receipt.Analysis revealed the dislodgement of the left ventricular contact spring within port, which caused reported event preventing insertion of lead.Manufacturing investigation was performed with undetermined cause.Functional testing performed after reinstalling contact spring was found to be normal.A manufacturing process anomaly may have occurred contributing to the reported event.A device history record (dhr) review was performed, and all required manufacturing processes and inspection steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.

• Brand Name: GALLANT BIPOLAR DF1 HF
• Common Device Name: NO MATCH
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 23524833
• Report Number: 2017865-2025-1004701
• Device Sequence Number: 10186826
• Product Code: NIK
• UDI-Device Identifier: 05415067050090
• UDI-Public: (01)05415067050090(10)A000175154(17)270531
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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: CDHFA500B
• Device Catalogue Number: CDHFA500B
• Device Lot Number: A000175154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/22/2025
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2025
• 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
• Patient Age: 87 YR
• Patient Sex: Female