MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CPS QUARTET INNER- CN-ALII 65CM; CATHETER, PERCUTANEOUS

Model Number	DS2N030-65
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Cardiac Perforation (2513)
Date of Event	03/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer report number: 2017865-2022-07634, 2017865-2022-07635, 2017865-2022-07637.It was reported that during left ventricular (lv) lead implant procedure the patient experienced a perforation resulting in tamponade.The physician performed pericardial drain to resolve the issue.The patient condition was stable.

• Brand Name: CPS QUARTET INNER- CN-ALII 65CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 14079109
• Report Number: 2017865-2022-07636
• Device Sequence Number: 13990219
• Product Code: DQY
• UDI-Device Identifier: 05415067005786
• UDI-Public: 05415067005786
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/11/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: DS2N030-65
• Device Catalogue Number: DS2N030-65
• Device Lot Number: 8098263
• 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: 03/23/2022
• Initial Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2021
• 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: Life Threatening
• Patient Age: 77 YR
• Patient Sex: Male