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

Model Number 2088TC/58

Device Problems Failure to Capture (1081); Device Dislodged or Dislocated (2923); Material Twisted/Bent (2981)

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

Event Date 10/04/2023

Event Type  malfunction  

Event Description

Related manufacturer reference number: (b)(4).It was reported that during an implant procedure, the lead implanted exhibited high pacing impedance and it was alleged that the lead was defective out of the packaging.Upon attempting to implant a second lead, the lead used dislodged, exhibited twisted insulation, and failed to capture.This lead was replaced and the procedure was completed successfully.The patient was stable throughout.

Manufacturer Narrative

The reported events were dislodgement, failure to capture, and insulation twisted.As received, a complete lead was returned in one piece for analysis.The reported events of failure to capture and insulation twisted were not confirmed.Electrical tests did not find any indication of conductor fractures or internal shorts.Visual inspection of the lead found helix was retracted and clogged with blood/tissue.All visual damages found on the lead consistent with procedural damage.X-ray examination found no anomalies noted to the lead body.After the lead was cleaned, the helix was able to be extended and retracted when torque was applied directly to the connector pin.The measured full helix extension length was within product specification.

• 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: 17993646
• MDR Text Key: 326354565
• Report Number: 2017865-2023-50424
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: A000147859
• 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: 10/04/2023
• Initial Date FDA Received: 10/24/2023
• Supplement Dates Manufacturer Received: 11/07/2023
• Supplement Dates FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 80 KG