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

Model Number 2088TC/58

Device Problems Signal Artifact/Noise (1036); Low impedance (2285); Material Twisted/Bent (2981)

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

Event Type  Injury  

Event Description

It was reported that the patient presented for a routine generator change procedure.Prior to the procedure, it was noted that the right ventricular lead exhibited noise and low pacing impedance.The lead was explanted and replaced.During the procedure, the physician noted the lead was kinked in several places.The patient was stable.

• 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: 18360500
• MDR Text Key: 330931416
• Report Number: 2017865-2023-95134
• 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
• Report Date: 12/19/2023

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: 09/30/2020
• Device Model Number: 2088TC/58
• Device Lot Number: P000051081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2017
• 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: 2088TC/52 TENDRILLEADS.; PM2272 ASSURITY MRI_PACEMAKER.
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 118 KG