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

Model Number 2088TC/58

Device Problems Capturing Problem (2891); Device Sensing Problem (2917); Device Dislodged or Dislocated (2923); Material Twisted/Bent (2981)

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

Event Date 10/11/2023

Event Type  Injury  

Event Description

Related manufacturer reference number:2017865-2023-51436.It was reported that the patient presented in clinic for a follow-up.Upon review it was discovered that the right ventricular lead exhibited high capture thresholds, a drop in sensing, and was dislodged.It was noted that the right ventricular lead and the atrial lead both looked bent at the header due to access placement and pulled back.Both leads were explanted and replaced.The patient was in stable condition.

Manufacturer Narrative

The reported events were dislodgement, bent header, inadequate capture, and r-wave amp variation.As received, a complete lead was returned in one piece for analysis.The reported events of bent header, inadequate capture, and r-wave amp variation were not confirmed.Visual inspection of the lead found the helix to be retracted and clogged with blood/tissue.X-ray examination found no anomalies to the lead body.Electrical testing did not find any indication of conductor fractures or internal shorts.The helix and the inner coil were damaged during performing the helix mechanism/extension length test.

• 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: 18052511
• MDR Text Key: 327126040
• Report Number: 2017865-2023-51438
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734502894
• UDI-Public: 05414734502894
• Combination Product (y/n): Y
• Reporter Country Code: AS
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2023

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 Model Number: 2088TC/58
• Device Lot Number: P000161624
• 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: 10/12/2023
• Initial Date FDA Received: 11/01/2023
• Supplement Dates Manufacturer Received: 11/30/2023; 12/15/2023
• Supplement Dates FDA Received: 12/06/2023; 12/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2023
• 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