MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) OPTISENSE LEAD; No Match

Model Number	1999/52
Medical Device Problem Codes	Break (1069); Over-Sensing (1438); Pacing Problem (1439); Device Sensing Problem (2917)
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 presented to the clinic for a generator change procedure.Prior to the procedure, device interrogation identified atrial lead noise oversensing, which resulted in inappropriate auto mode switch (ams).The noise had been previously noted on stored electrograms (egms) but was not reproducible at the time of evaluation.Additionally, the atrial lead demonstrated variable p-wave amplitude.During the procedure, the atrial lead was assessed, and insulation damage was identified.As a result, the physician elected to cap and replace the atrial lead during the same procedure on (b)(6) 2026.The patient remained stable throughout the procedure.

• Brand Name: OPTISENSE LEAD
• Common Device Name: No Match
• 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: 25077130
• Report Number: 2017865-2026-09205
• Device Sequence Number: 10688898
• Product Code: NVN
• UDI-Device Identifier: 05414734502481
• UDI-Public: (01)05414734502481(10)3880002(17)151231
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P960013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 05/05/2026

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 Expiration Date: 12/31/2015
• Device Model Number: 1999/52
• Device Lot Number: 3880002
• 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: 04/22/2026
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2012
• 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: DURATA LEAD; QUADRA ASSURA ICD; QUARTET LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White