MAUDE Adverse Event Report: ABBOTT DURATA STS OPTIM PASSIVE FIXATION; Implantable cardioverter defibrillator (non-CRT)

Model Number	7170/65
Medical Device Problem Codes	Failure to Convert Rhythm (1540); Low impedance (2285)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	03/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had ventricular tachycardia (vt).The device failed to deliver high voltage therapy due to low defibrillation impedance observed on the right ventricular (rv) lead.Subsequently, the device appropriately detected the vt and successfully delivered high voltage therapy.During in-clinic follow-up, the device was reprogrammed to resolve the event.The patient was stable and there were no adverse consequences.

• Brand Name: DURATA STS OPTIM PASSIVE FIXATION
• Common Device Name: Implantable cardioverter defibrillator (non-CRT)
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18856569
• Report Number: 2017865-2024-34336
• Device Sequence Number: 19661730
• Product Code: LWS
• UDI-Device Identifier: 05414734502436
• UDI-Public: 05414734502436
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/07/2011
• Device Model Number: 7170/65
• Device Lot Number: 2912758
• 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: 03/02/2024
• Initial Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2008
• 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
• Patient Sex: Unknown