MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number	LDA220Q/58
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Capture (1081); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented for a follow up in clinic.It was noted that no capture was observed on the right atrial (ra) and right ventricular (rv) leads.Imaging confirmed that the ra and rv leads had pulled back into the superior vena cava (svc).The ra and rv leads were explanted and replaced successfully.The patient was stable throughout with no complications.
Additional Manufacturer Narrative
Correction section d4 and h4: the product serial and model # with corresponding product details were corrected.The serial should have been (b)(6) instead of (b)(6).(the udi #, lot #, expiration date, manufacturing dates were also updated to match the correct serial).
Event or Problem Description
New information received notes that some ventricular lead noise sparked initial interrogation but did not trigger any inappropriate event on the right ventricular (rv) lead prior to the procedure.The patient was stable before, during, and after the procedure.Follow up checks were within normal parameters.
Additional Manufacturer Narrative
The reported events were dislodgment, failure to capture, and noise.As received, a complete lead was returned for analysis.Visual examination of the lead found the helix retracted and clogged with blood / tissue.After cleaning and applying torque directly to the connector pin, the helix could be extended and retracted.The full helix extension length was measured within specification.The reported events of failure to capture and noise were not confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.

• Brand Name: OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR
• Common Device Name: PERMANENT DEFIBRILLATOR ELECTRODES
• 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: 24735185
• Report Number: 2017865-2026-06513
• Device Sequence Number: 15774513
• Product Code: NVY
• UDI-Device Identifier: 05414734507356
• UDI-Public: (01)05414734507356(10)A000177326(17)280731
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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,Followup,Followup
• Report Date (Section B): 04/29/2026

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: LDA220Q/58
• Device Lot Number: A000177326
• 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: 03/12/2026
• Supplement Date Received by Manufacturer: 03/12/2026; 03/31/2026; 04/28/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/01/2026; 04/17/2026; 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2025
• 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: GALLANT DR ICD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 80 KG