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

Model Number	1999/52
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Review of the sterilization records confirmed normal sterilization cycles for the products.The product was returned, and visual inspection was normal.The cause of infection could not be traced to the device.
Event or Problem Description
It was reported that the patient presented to the hospital for bi-atrial crt-d system extraction due to infection.Echocardiography was performed and revealed methicillin-susceptible staphylococcus aureus (mssa) infection with unconfirmed lead vegetation.The implantable cardioverter-defibrillator (icd), right atrial (ra), left atrial (la), right ventricular (rv), and lateral coronary sinus leads were explanted and replaced with a new contralateral crt-d system.The cause of the infection was not definitively confirmed; however, it was suspected to be associated with a recent gastrointestinal diagnostic procedure.The patient¿s condition remained stable.

• 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: 25085475
• Report Number: 2017865-2026-09231
• Device Sequence Number: 10402888
• Product Code: NVN
• UDI-Device Identifier: 05414734502481
• UDI-Public: (01)05414734502481(10)3836227(17)151031
• 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: 2012
• 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): 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: 10/31/2015
• Device Model Number: 1999/52
• Device Lot Number: 3836227
• 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: 04/07/2026
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2012
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 130 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White