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

Model Number 2088TC/58

Device Problems Failure to Capture (1081); Device Sensing Problem (2917); Device Dislodged or Dislocated (2923)

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

Event Date 03/04/2024

Event Type  Injury  

Event Description

It was reported that the right ventricular (rv) lead dislodged.Upon further interrogation, it was noted that the rv lead exhibited failure to capture and reduced r-wave sensing.The rv lead was explanted and replaced.The patient was in stable condition.

Manufacturer Narrative

The reported events were lead dislodgement, loss of capture and r-wave amp variation.A complete lead was returned in one piece with the helix retracted and clogged blood/tissue.After cleaning and applying the torque directly to the connector pin, the helix could be extended and retracted.The full helix extension length was measured to be within specification.The reported events of loss of capture and r-wave amp variation were not confirmed.Electrical testing was normal with no anomalies found.

• 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: 18956756
• MDR Text Key: 338305129
• Report Number: 2017865-2024-35616
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

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: A000136474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2023
• 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 MRI PACEMAKER.; TENDRIL LEAD.
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female