MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DURATA STS OPTIM ACTIVE FIXATION; DEFIBRILLATION LEAD

Model Number 7120/65

Device Problem Failure to Disconnect (2541)

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

Event Date 03/27/2023

Event Type  Injury  

Event Description

Related manufacturer report number: 2017865-2023-17614, related manufacturer report number: 2017865-2023-17615.It was reported that a patient presented with oversensing noise on the atrial lead resulting in inappropriate mode switch and pacing inhibition.During lead revision, the physician noted the atrial lead, left ventricular (lv) lead, and right ventricular (rv) lead were adhered to each other and elected to extract all three leads.During the procedure, the patient developed pericardial effusion that was promptly repaired.The physician implanted two epicardial leads and completed the procedure.The patient condition was stable after the procedure.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION
• 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: 16748203
• MDR Text Key: 313387135
• Report Number: 2017865-2023-17616
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 05414734502092
• UDI-Public: 05414734502092
• 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
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2011
• Device Model Number: 7120/65
• Device Catalogue Number: 7120-65
• Device Lot Number: 0002662238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2008
• 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: UNIFY ASSURA ICD
• Patient Outcome(s): Life Threatening
• Patient Age: 54 YR
• Patient Sex: Male