MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) TENDRIL STS; NO MATCH

Model Number 2088TC/46

Device Problems Failure to Capture (1081); Device Sensing Problem (2917)

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513)

Event Date 03/18/2024

Event Type  Injury  

Manufacturer Narrative

A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.

Event Description

It was reported that device interrogation showed the right atrial (ra) lead was not capturing and p wave sensing had dropped.The patient has had multiple chest x-rays, evidence of ra lead perforation that can be seen via review of x-ray.It was found that the patient experienced cardiac tamponade and pericardiocentesis was performed.Device reprogramming was also made.The patient was in stable condition.

Event Description

New information received indicated that the right atrial (ra) lead was repositioned on (b)(6) 2024 due to the previously reported perforation.The patient was stable before, during, and post-procedure.

• Brand Name: TENDRIL STS
• Type of Device: NO MATCH
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 19050761
• MDR Text Key: 339480932
• Report Number: 2017865-2024-37790
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734502870
• UDI-Public: (01)05414734502870(10)P000175570(17)260630
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P960013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

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
• Device Operator: Health Professional
• Device Model Number: 2088TC/46
• Device Lot Number: P000175570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/05/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DURATA; GALLANT; QUARTET
• Patient Outcome(s): Required Intervention
• Patient Sex: Male