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

Model Number 7122Q/58

Device Problems Failure to Capture (1081); Retraction Problem (1536); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285); Device Sensing Problem (2917); Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 12/26/2023

Event Type  Injury  

Event Description

It was reported that the right ventricular lead had dislodged.The lead was further noted to exhibit capture failure and low impedance.Additionally, the patient received an inappropriate shock due to the dislodgement.During the attempt to reposition the lead, the helix would not retract.The rv lead was explanted and replaced.There were no adverse health consequences, the patient was stable.

Event Description

It was reported that the patient presented to the clinic feeling bad.It was found that the right ventricular lead had dislodged.Device interrogation noted no capture, sensing had dropped, and the pacing impedance had declined since implant.Additionally, the patient received an inappropriate shock due to the dislodgement.During the attempt to reposition the lead, the helix would not retract.The rv lead was explanted and replaced.There were no adverse health consequences, the patient was stable.

• 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: 18512428
• MDR Text Key: 332869113
• Report Number: 2017865-2024-01194
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

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/58
• Device Lot Number: A000143884
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/26/2023
• Initial Date FDA Received: 01/15/2024
• Supplement Dates Manufacturer Received: 03/25/2024
• Supplement Dates FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2023
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 131 KG