MAUDE Adverse Event Report: ABBOTT DURATA STS OPTIM PASSIVE FIXATION; DEFIBRILLATION LEAD

Model Number	7170/65
Medical Device Problem Codes	Break (1069); High impedance (1291); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that high pacing impedance, noise leading to oversensing, and delivery of inappropriate high voltage therapy were observed on the right ventricular (rv).Noise could be reproduced with provocative testing and lead damage near the device header was the suspected cause of the event.The lead was deactivated.The lead was capped and replaced to resolve the event.The patient was stable and there were no adverse consequences.

• Brand Name: DURATA STS OPTIM PASSIVE FIXATION
• Common Device Name: DEFIBRILLATION LEAD
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 14835851
• Report Number: 2017865-2022-13461
• Device Sequence Number: 4794258
• 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: 2010
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2022

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: 09/30/2012
• Device Model Number: 7170/65
• Device Catalogue Number: 7170-65
• Device Lot Number: 2914147
• 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: 06/13/2022
• Supplement Date Received by Manufacturer: 07/11/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 07/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2009
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown