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 Retraction Problem (1536); Failure to Advance (2524); Capturing Problem (2891); Device Sensing Problem (2917)

Patient Problem Cardiac Perforation (2513)

Event Date 03/27/2023

Event Type  Injury  

Event Description

It was reported that the patient presented to the hospital for a follow-up on (b)(6) 2023.During examination of lead, it was noted that there was unspecified r-wave sensing issue and high capture threshold on the right ventricular (rv) lead.After further assessment in clinic, it was confirmed that there was cardiac perforation caused by rv lead where the lead possible passed through the myocardium.While attempting to reposition the lead, the helix failed to retract and the stylet could not be advanced into the lead.The rv lead was explanted and replaced on (b)(6) 2023.The patient was in stable condition throughout.

Manufacturer Narrative

The reported events of a helix mechanism issue and the stylet could not insert were confirmed.The reported events of high threshold and sensing issue were not confirmed.As received, a complete lead was returned in one piece with the helix partially extended and clogged blood/tissue.A tip stiffness test was performed and the results within specification.X-ray inspection found the inner coil over torqued consistent with the procedural damage.After cleaning and by applying toque directly to the inner coil, the helix could be extended and retracted.The full helix extension length was measured to be within specification.Electrical testing did not find any indication of conductor fractures or internal shorts.The cause of the reported events of a helix mechanism issue and the stylet could not insert were isolated to over torqued of the inner coil in the connector region and the helix being clogged with blood/tissue.

• 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: 16748840
• MDR Text Key: 313388327
• Report Number: 2017865-2023-17665
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734503174
• UDI-Public: 05414734503174
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P950022
• 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: 05/26/2023

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: 7122Q/58
• Device Catalogue Number: 7122Q-58
• Device Lot Number: A000129062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 04/16/2023
• Supplement Dates Manufacturer Received: 05/12/2023
• Supplement Dates FDA Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2022
• 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
• Treatment: GALLANT.; TENDRIL.
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 102 KG