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

Model Number 2088TC/58

Device Problems Failure to Sense (1559); Insufficient Information (3190)

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

Event Date 12/22/2023

Event Type  Injury  

Event Description

It was reported that a hospital implant registration form was received and indicated that the lead was replaced for an unknown malfunction.

Manufacturer Narrative

Correction: the correct medical device problem code should have been "failure to sense", rather than "insufficient information".It was reported that a hospital implant registration form was received and indicated that the lead was replaced on (b)(6) 2023 due to failure to sense.", rather than "it was reported that a hospital implant registration form was received and indicated that the lead was replaced for an unknown malfunction.".

Event Description

It was reported that a hospital implant registration form was received and indicated that the lead was replaced on (b)(6) 2023 due to failure to sense.

• 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: 18637849
• MDR Text Key: 334489924
• Report Number: 2017865-2024-03700
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: P960013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2024

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: P000146186
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 01/18/2024
• Supplement Dates FDA Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2022
• 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
• Patient Outcome(s): Required Intervention