MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) OPTISENSE LEAD; Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

Model Number	1999/52
Medical Device Problem Codes	Signal Artifact/Noise (1036); Therapy Delivered to Incorrect Body Area (1508)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	08/17/2026
Type of Reportable Event	Malfunction

• Brand Name: OPTISENSE LEAD
• Common Device Name: Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker 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: 50632303
• Report Number: 2017865-2026-18839
• Device Sequence Number: 13288053
• Product Code: NVN
• UDI-Device Identifier: 05414734502481
• UDI-Public: (01)05414734502481(10)3552558(17)141031
• Combination Product (Y/N): Y
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P960013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/05/2026

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: 10/31/2014
• Device Model Number: 1999/52
• Device Lot Number: 3552558
• 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: 09/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2011
• 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: 74 YR
• Patient Sex: Male