MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) TENDRIL STS; PERMANENT PACEMAKER ELECTRODE

Model Number 2088TC/58

Device Problems Break (1069); Failure to Capture (1081); Difficult to Insert (1316); Retraction Problem (1536); Failure to Sense (1559); Difficult to Advance (2920); Material Twisted/Bent (2981)

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

Event Date 05/02/2022

Event Type  malfunction  

Manufacturer Narrative

Further information was requested but not received.

Event Description

It was reported that the patient presented for an implant procedure.During the procedure, it was noted that the right ventricle (rv) lead exhibited difficulty inserting the stylet. the rv lead was also failing to capture and failing to sense.During the rv lead removal, it was noted that the lead helix was failing to retract and the lead insulation was found twisted.The rv lead was not used.The physician continued to use another rv lead and completed the procedure.The patient was in stable condition.

Manufacturer Narrative

Correction: the correct complaint code should have been difficult to advance, rather than difficult to insert.

Event Description

New information noted that the right ventricle lead was found insulation damage.

Manufacturer Narrative

A device history record (dhr) review was performed and all required manufacturing processes and inspection steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.A complete lead was returned in one piece with the helix extended and clogged with blood/tissue.X-ray examination revealed that the inner coil at the connector region was over-torqued and some filars were broken consistent with procedural damage.Visual inspection of the lead found insulation was twisted.The helix could be retracted and extended after cleaning and applying torque to the inner coil.The helix extension length was measured within specification.Electrical testing was normal except the internal shorts were noted due to the over-torqued inner coil.The cause of the reported events of difficulty inserting a stylet, failure to capture, failure to sense and twisted insulation was due to the over-torqued inner coil at the connector region, while the reported event of helix mechanism issue was due to the helix being clogged with blood/tissue and over-torqued inner coil at the connector region consistent with procedural damage.

• Brand Name: TENDRIL STS
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 14859341
• MDR Text Key: 295887795
• Report Number: 2017865-2022-13583
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734502894
• UDI-Public: 05414734502894
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: P960013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2088TC/58
• Device Catalogue Number: 2088TC-58
• Device Lot Number: P000135917
• 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: 10/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2021
• 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: STYLET
• Patient Age: 71 YR
• Patient Sex: Male