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

Model Number 7120Q/65

Device Problems Difficult to Fold, Unfold or Collapse (1254); Therapy Delivered to Incorrect Body Area (1508); Retraction Problem (1536); Capturing Problem (2891)

Patient Problems Discomfort (2330); Cardiac Perforation (2513)

Event Date 08/09/2023

Event Type  Injury  

Event Description

It was reported during in clinic follow up that the right ventricular lead exhibited high capture threshold.Muscle stimulation lead to the patient feeling discomfort.Cardiac perforation was suspected.During lead revision, the helix was difficult to retract and failed to extend.The lead was instead explanted and successfully replaced.The patient was stable.

Manufacturer Narrative

The reported events were suspected cardiac perforation, helix mechanism issue, high pacing threshold and muscle stimulation.As received, a complete lead was returned in one piece.Visual inspection of the lead found the helix was retracted clogged with blood/tissue.The reported event of helix mechanism issue was confirmed while the reported event of high pacing threshold was not confirmed.X-ray showed that the inner coil inside the connector region was over torqued consistent with procedural damage.After cleaning blood/tissue from the helix and applying torque to the inner coil, the helix could be extended and retracted.The full measured helix extension length was within specification.The cause of the reported event of helix mechanism issue was isolated to the helix being clogged with blood/tissue and over torque of the inner coil.Electrical tests and x-ray examination did not find any indication of conductor fractures or internal shorts.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: 17613401
• MDR Text Key: 321855898
• Report Number: 2017865-2023-39226
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734503204
• UDI-Public: 05414734503204
• 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: 10/02/2023

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: 7120Q/65
• Device Lot Number: A000138944
• 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: 08/09/2023
• Initial Date FDA Received: 08/24/2023
• Supplement Dates Manufacturer Received: 09/29/2023
• Supplement Dates FDA Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2023
• 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: QUADRA ASSURA; QUARTET; TENDRIL
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female