MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DURATA STS OPTIM ACTIVE FIXATION; DEFIBRILLATION LEAD

Model Number 7122/65

Device Problems Use of Device Problem (1670); Capturing Problem (2891)

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

Event Date 02/28/2023

Event Type  malfunction  

Event Description

It was reported that during the implant.Device interrogation revealed pacing issue and was unable to implant on the right ventricular (rv) lead.The physician elected to abandon the implant.The patient was in stable condition.

Manufacturer Narrative

The reported events were pacing issue and unable to implant.As received, a complete lead was returned in one piece.Electrical, mechanical, and visual analysis was normal with no anomalies found.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION
• Type of Device: DEFIBRILLATION LEAD
• 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: 16569641
• MDR Text Key: 311560961
• Report Number: 2017865-2023-14063
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 05414734502153
• UDI-Public: 05414734502153
• Combination Product (y/n): Y
• Reporter Country Code: IN
• PMA/PMN Number: P950022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2023

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: 7122/65
• Device Catalogue Number: 7122-65
• Device Lot Number: A000127918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2023
• Initial Date FDA Received: 03/18/2023
• Supplement Dates Manufacturer Received: 04/13/2023
• Supplement Dates FDA Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2022
• 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