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

Model Number 2088TC/46

Device Problems Difficult to Fold, Unfold or Collapse (1254); Capturing Problem (2891); Device Sensing Problem (2917); Device Dislodged or Dislocated (2923)

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

Event Date 03/12/2024

Event Type  Injury  

Event Description

Related manufacturer reference number: 2017865-2024-37178.Related manufacturer reference number: 2017865-2024-37180.It was reported that the patient came into the clinic for a follow-up.During device interrogation, atrial sensing and threshold were found to have changed since the previous check.The patient had reported experiencing a seizure around (b)(6) 2024 and had lost consciousness and had fallen.Chest x-ray showed the device and the right atrial (ra) lead and right ventricular (rv) lead had moved.The patient was scheduled for repositioning of the device system.The patient had no complaints of any symptoms and was stable during and after the follow-up check.On (b)(6) 2024, the patient presented for a revision.The device and the rv lead were both repositioned successfully.The ra lead was repositioned but the helix would not extend.The doctor removed the ra lead and appeared to have body tissue stuck in the coils, which prevented it from turning out again.A new ra lead was implanted.The patient's condition before, during, and after the procedure was stable.

Manufacturer Narrative

The reported event of dislodgement, inadequate capture, and sensing amp variation was not confirmed, while the reported helix mechanism issue was confirmed.As received, a complete lead with a stylet was returned in one piece.Electrical testing did not find any indication of conductor fractures or internal shorts.Visual inspection of the lead found the helix retracted and clogged with blood/tissue.X-ray examination found the over-torqued inner coil, consistent with procedural damage.After cleaning and applying torque to the inner coil, the helix could be extended and retracted.The measured full helix extension length was within product specification.The cause of the reported event of helix mechanism issue was isolated to an over-torqued inner coil and clogged helix.

• 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: 19001442
• MDR Text Key: 338883181
• Report Number: 2017865-2024-37179
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734502870
• UDI-Public: 05414734502870
• 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: 05/03/2024

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/46
• Device Lot Number: P000175315
• 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: 03/12/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 89 KG