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

Model Number 2088TC/58

Device Problems Device Sensing Problem (2917); Device Dislodged or Dislocated (2923); Material Twisted/Bent (2981)

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

Event Date 09/28/2023

Event Type  malfunction  

Event Description

It was reported a patient presented for an implant procedure on (b)(6) 2023.During the operation, the right ventricular (rv) lead presented with r-wave amplitude variation due to partial lead dislodgement.The lead was not used and replaced within the same operation, it was also noted the lead was bumpy and the insulation was twisted.Post-procedure the patient was stable.

Manufacturer Narrative

The reported events were lead dislodgement, r-wave amplitude variation and ¿lead was bumpy, and insulation twisted¿.As received, a complete lead was returned in one piece with the helix found retracted and clogged with dried blood/tissue.After cleaning, the helix can be extended and retracted by applying torque directly at the connector pin.The measured full helix extension length was within specification.The reported event of r-wave amplitude variation was not confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.The reported event of ¿lead was bumpy, and insulation twisted¿ was not confirmed.Visual and x-ray inspections of the lead did not find any 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: 17878047
• MDR Text Key: 325008307
• Report Number: 2017865-2023-47834
• 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: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2088TC/58
• Device Lot Number: A000147105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2023
• 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
• Patient Age: 61 YR
• Patient Sex: Female