MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; DEFIBRILLATION LEAD

Model Number 7122Q/58

Device Problems Difficult to Fold, Unfold or Collapse (1254); Retraction Problem (1536); Failure to Advance (2524); Capturing Problem (2891); Device Sensing Problem (2917)

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

Event Date 04/18/2023

Event Type  malfunction  

Event Description

During an initial implant procedure on (b)(6) 2023, it was reported that the right ventricular (rv) lead had high capture thresholds and device sensing issues in the form of r-wave amplitude variation.The physician elected to reposition the rv lead, but during these attempts the physician experienced difficulties with both retracting and extending the helix, as well as advancing the stylet.The physician decided to replace the rv lead and a new rv lead was successfully implanted.The patient was stable throughout the procedure.

Manufacturer Narrative

The reported events of helix mechanism issue and failure to advance stylet were confirmed, but the reported events of inadequate capture and r-wave amplitude variation were not confirmed.As received, a complete lead was returned in one piece with the helix extended and clogged with blood/tissue.It was noted that the inner coil at the connector region was overortorqued consistent with procedural damage.The cause of the reported event of helix mechanism issue was isolated to the helix being clogged with blood/tissue and overtorqued inner coil at the connector region consistent with procedural damage.The latter was also determined to be the cause of the reported event of failure to advance stylet.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
• 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: 16824029
• MDR Text Key: 314101870
• Report Number: 2017865-2023-18592
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734503174
• UDI-Public: 05414734503174
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 06/12/2023

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: 7122Q/58
• Device Catalogue Number: 7122Q-58
• Device Lot Number: A000137067
• 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: 04/18/2023
• Initial Date FDA Received: 04/27/2023
• Supplement Dates Manufacturer Received: 06/08/2023
• Supplement Dates FDA Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2023
• 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