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

Model Number 2088TC/52

Device Problem Insufficient Information (3190)

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

Event Date 05/18/2020

Event Type  Injury  

Event Description

It was reported that the right ventricular (rv) lead was capped and replaced on (b)(6) 2020 due to unknown reason.During an unrelated procedure, the capped rv lead was explanted.The patient was in stable condition.

Manufacturer Narrative

The lead was returned with insufficient information.A complete lead was returned in one piece.Visual examination of the lead found external abrasions breaching the outer insulation and exposing the outer coil caused by friction to the device can located proximal from the suture tie impressions.Electrical testing of the lead found an internal short between the inner coil and outer coil conductor paths due to procedural damage.Electrical testing of the lead was normal with no anomalies.

• 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: 18744645
• MDR Text Key: 335809126
• Report Number: 2017865-2024-33136
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734502887
• UDI-Public: 05414734502887
• 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: 05/20/2024

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 Expiration Date: 06/30/2014
• Device Model Number: 2088TC/52
• Device Lot Number: 3425647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/20/2024
• Supplement Dates Manufacturer Received: 05/17/2024
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2011
• 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: ATRIAL LEAD; PACEMAKER
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female