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

Model Number 2088TC

Device Problems Capturing Problem (2891); Insufficient Information (3190)

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

Event Date 01/30/2024

Event Type  malfunction  

Event Description

It was reported that the patient presented for a procedure.During the procedure, it was noted that right ventricle (rv) lead exhibited an unknown malfunction.However, the rv lead was successfully implanted.The patient was in stable condition.

Manufacturer Narrative

Further information was requested but not received.

Event Description

It was reported that the patient presented for a procedure.During the procedure, it was noted that right ventricle (rv) lead exhibited a high capture threshold.However, the rv lead was successfully implanted.The patient was in stable condition.

Manufacturer Narrative

Correction: the correct medical device problem code should have been "capturing problem", rather than "insufficient information".The correct event description should have been "it was reported that the patient presented for a procedure.During the procedure, it was noted that right ventricle (rv) lead exhibited a high capture threshold.However, the rv lead was successfully implanted.The patient was in stable condition", rather than "it was reported that the patient presented for a procedure.During the procedure, it was noted that right ventricle (rv) lead exhibited an unknown malfunction.However, the rv lead was successfully implanted.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: 18729054
• MDR Text Key: 335719709
• Report Number: 2017865-2024-32964
• 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: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2088TC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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