MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) OPTISENSE LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number	1999/40
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	06/23/2021
Type of Reportable Event	Death
Event or Problem Description
It was reported that a patient presented in-clinic for a lead extraction due to oversensing of noise observed on the right atrial (ra) lead.During the procedure and after the ra lead was removed, cardiac perforation occurred and an effusion developed.This was confirmed via transesophageal echocardiography (tee).Despite a resuscitative thoracotomy being performed, the patient passed away on (b)(6) 2021.
Additional Manufacturer Narrative
A partial lead was returned for analysis in 4 segments.The damage found was sustained during procedure.The portion of the lead that was returned was otherwise normal.
Event or Problem Description
New information received notes that the physician alleged fibrous tissue in-growth on the lead, not the lead itself as the primary cause of the reported event.

• Brand Name: OPTISENSE LEAD
• Common Device Name: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 12153902
• Report Number: 2017865-2021-25089
• Device Sequence Number: 3800538
• Product Code: NVN
• UDI-Device Identifier: 05414734502467
• UDI-Public: 05414734502467
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P960013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2021

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: 03/31/2017
• Device Model Number: 1999/40
• Device Catalogue Number: 1999-40
• Device Lot Number: 4530398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 07/23/2021; 08/12/2021
• Initial Report FDA Received Date: 07/12/2021
• Supplement Report FDA Received Date: 08/12/2021; 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 109