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

Model Number 1882TC/46

Device Problems Low impedance (2285); Device Sensing Problem (2917)

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

Event Date 04/23/2024

Event Type  Injury  

Event Description

It was reported that the patient presented for a routine generator exchange procedure.Prior to the procedure, upon interrogation, it was noted that the right atrial (ra) lead exhibited a low pacing impedance and decreasing in sensing.The ra lead was capped and replaced on (b)(6) 2024.The patient was in stable condition.

• Brand Name: TENDRIL ST
• 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: 19199718
• MDR Text Key: 341237055
• Report Number: 2017865-2024-39961
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734501774
• UDI-Public: (01)05414734501774(10)4073537(17)160531
• 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
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Model Number: 1882TC/46
• Device Lot Number: 4073537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/11/2013
• 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: TENDRIL LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female