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	Failure to Disconnect (2541); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that episodes of noise causing inappropriate rv (right ventricular) pacing, mode switching, and pacing inhibition were noted on the right atrial (ra) lead.Fluoroscopy showed no ra lead damage, but it was difficult to place the locking stylet down the lead past the clavicle area.Low sensing and decreased pacing impedance were noted during the procedure.During revision, the ra and rv leads were found adhered together; subsequent laser extraction of the ra lead inadvertently displaced the rv lead due to these attachments.Both leads were explanted and replaced.The patient was in stable condition with no adverse events.

• 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: 25661144
• Report Number: 2017865-2026-13478
• Device Sequence Number: 12187898
• Product Code: NVY
• UDI-Device Identifier: 05414734507356
• UDI-Public: (01)05414734507356(10)A000040853(17)180531
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted 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): 06/29/2026

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: 05/31/2018
• Device Model Number: LDA220Q/58
• Device Lot Number: A000040853
• 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: 06/09/2026
• Initial Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2017
• 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: FORTIFY ASSURA
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 77 KG