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

Model Number 2088TC/58

Device Problem Device Sensing Problem (2917)

Patient Problems Arrhythmia (1721); Cardiac Perforation (2513)

Event Type  Injury  

Event Description

It was reported through the heart rhythm society identifying a right ventricular (rv) lead left bundle branch area pacing that may be related to a cardiac perforation resulting in ventricular tachycardia (vt) and decreased r-wave sensing.Initially, the patient was asymptomatic and the vt was hemodynamically tolerated.It was terminated with intravenous lidocaine.A transthoracic echocardiogram was performed and revealed interventricular septal perforation into the left ventricular cavity.Telemetry revealed premature ventricular contractions (pvc).Pvc¿s were suspected to be due to the perforation as they were not present prior to the event.The pvcs and episodes of nonsustained vt continued to occur until the event was resolved by a lead revision.The rv lead was removed.The patient was in stable condition.

• 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: 18969193
• MDR Text Key: 338496255
• Report Number: 2017865-2024-35789
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734502894
• UDI-Public: 05414734502894
• 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: Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2024

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/58
• Device Lot Number: A000132564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2022
• 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: MEDTRONIC AZURE; MEDTRONIC RA LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male