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

Model Number 2088TC/52

Device Problems Over-Sensing (1438); Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Further information was requested but not received.

Event Description

Related manufacturer reference number: 2017865-2024-00475.It was reported that the right ventricular (rv) lead exhibited noise.The rv lead was explanted and replaced.It was also observed that the right atrial (ra) lead was explanted and replaced, due to an unknown issue.The patient had no adverse consequences.

Event Description

New information received notes that the right ventricular lead (rv) lead was oversensing noise which led to pacing inhibition.The right atrial (ra) lead had a lead dislodgement during the explant procedure of the rv lead and also had noise oversensing which was seen via merlin.Net transmission.

• 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: 18476905
• MDR Text Key: 332453116
• Report Number: 2017865-2024-00476
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734502887
• UDI-Public: 05414734502887
• 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: 01/29/2024

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 Expiration Date: 01/31/2023
• Device Model Number: 2088TC/52
• Device Lot Number: A000093849
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 01/09/2024
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2020
• 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: ASSURITY.
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male