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

Model Number 7122Q/65

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

Patient Problems Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 09/05/2023

Event Type  Injury  

Event Description

It was reported that the right ventricular (rv) lead exhibited high capture thresholds and low sensing.Transesophageal echocardiography (tee) was performed revealing a mild effusion due to the perforation.During the revision, the helix would not extend and retract appropriately, and as a result, the rv lead was explanted and replaced.The patient was in stable condition.

Manufacturer Narrative

The reported event of cardiac perforation, high capture threshold, and low r-wave amplitude was not confirmed, while the reported event of helix mechanism issue was confirmed.As received, a complete lead was returned in one piece for analysis.Electrical testing did not find any indication of conductor fractures or internal shorts.Visual and x-ray inspection of the lead did not find any anomalies.Visual inspection found the helix retracted and clogged with dried blood.X-ray examination found the inner coil over-torqued at the connector region, consistent with procedural damage.After cleaning, cutting the lead, and applying torque directly to the inner coil, the helix could be extended and retracted.The helix extension length was measured within specification.The cause of the reported helix event was isolated to an over-torqued inner coil, consistent with procedural damage and a clogged helix.A tip stiffness test was performed, and the results were within specification.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• 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: 17807797
• MDR Text Key: 324140017
• Report Number: 2017865-2023-46857
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734503341
• UDI-Public: 05414734503341
• 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: 01/29/2024

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/65
• Device Lot Number: A000142727
• 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: 09/07/2023
• Initial Date FDA Received: 09/25/2023
• Supplement Dates Manufacturer Received: 01/26/2024
• Supplement Dates FDA Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2023
• 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
• Treatment: GALLANT ICD; TENDRIL RA LEAD
• Patient Outcome(s): Required Intervention
• Patient Sex: Male