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 Failure to Capture (1081); Therapy Delivered to Incorrect Body Area (1508); Retraction Problem (1536); Low impedance (2285); Device Sensing Problem (2917)

Patient Problems Low Blood Pressure/ Hypotension (1914); Discomfort (2330); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 02/10/2023

Event Type  Injury  

Event Description

It was reported that the patient presented to the hospital for a follow-up on 10 feb 2023 after experiencing chest pain.During examination of lead, it was noted that there was decreased r-wave sensing, low pacing lead impedance, no capture threshold at higher outputs and muscle stimulations to the lower chest wall on the right ventricular (rv) lead.After further assessment in clinic, ultrasound and chest x-ray confirmed cardiac perforation caused by rv lead.The physician performed pericardiocentesis to relieve chest pain and improve dropping blood pressure.The rv lead was explanted and replaced on (b)(6) 2023.The patient was in stable condition throughout.

Manufacturer Narrative

A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.The reported events were r-wave amplitude variation, low pacing lead impedance, failure to capture, muscle stimulation, cardiac perforation and helix mechanism issue.The reported event of helix mechanism issue was confirmed but the reported events of r-wave amplitude variation, low pacing lead impedance and failure to capture were not confirmed.As received, a complete lead was returned in one piece with the helix retracted and clogged with blood/tissue.X-ray examination showed that the inner coil at the connector region was slightly overtorqued consistent with procedural damage.X-ray examination of the helix region found no anomalies or distortion of the helix that would have contributed to the helix mechanism issue reported in the field.After cleaning and by applying torque to the connector pin, the helix could be extended and retracted, and helix extension length was measured within specification.Tip stiffness test was performed due to the reported event of cardiac perforation and the results were within specification.Electrical testing did not find any indication of conductor fractures or internal shorts.Visual inspection of the lead did not find any anomalies except for the damage found consistent with procedural damage.The cause of the reported event of helix mechanism issue was due to the helix clogged with blood/tissue and slightly over torqued inner coil consistent with procedural damage.

Event Description

New information received notes the right ventricular (rv) lead helix would not retract during the lead revision on (b)(6) 2023.Post-procedure the patient was stable.

• 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: 16464851
• MDR Text Key: 310488491
• Report Number: 2017865-2023-11517
• 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: 05/31/2023

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: A000124499
• 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: 02/10/2023
• Initial Date FDA Received: 03/01/2023
• Supplement Dates Manufacturer Received: 05/12/2023
• Supplement Dates FDA Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2022
• 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: 67 YR
• Patient Sex: Male