MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DURATA STS OPTIM PASSIVE FIXATION; Implantable cardioverter defibrillator (non-CRT)

Model Number	7170/65
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	07/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, that the patient experienced an episode of asystole.The system was interrogated, and all parameters were normal.The episode of asystole was caught on electrocardiogram.And multiple episodes of right ventricular oversensing were detected by the algorithm on the right ventricular (rv) lead.Programming changes to counter the oversensing were made.During interrogation, some missed beats were noted with very short runs of noise on the rv lead.The physician therefore, opted to implant a sense/pace lead.A new rv lead was implanted in the high mid septum.And the terminal pin was placed in the sense/pace port of the existing generator.The existing rv lead was left in place, but the sense/pace terminal was capped (b)(6) 2023.A defibrillation test was completed successfully.The patient spent the night per protocol at the hospital.The device was evaluated the following morning and all tests were good.The patient was stable immediately after procedure, the following morning.And was discharged the day after the procedure.

• Brand Name: DURATA STS OPTIM PASSIVE FIXATION
• Common Device Name: Implantable cardioverter defibrillator (non-CRT)
• 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: 17438693
• Report Number: 2017865-2023-37292
• Device Sequence Number: 16822420
• Product Code: LWS
• UDI-Device Identifier: 05414734502436
• UDI-Public: 05414734502436
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/01/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 7170/65
• Device Lot Number: S000029408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ELLIPSE VR ICD; TENDRIL STS
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Female