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

Model Number	7171/65
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
It was reported that when the patient presented in clinic for a routine follow up, increase in capture threshold and pacing lead impedance were observed.The lead impedance increase was significant.Lead revision will be scheduled.The patient was stable.
Event or Problem Description
New information received notes that the patient presented in clinic for a routine follow up.Upon interrogation, capture threshold and pacing lead impedance continued increasing.Isometric testing was performed, but no oversensing was noted.The patient will be monitored remotely, and the lead will be reevaluated at time of the device replacement.The patient was stable and was discharged.
Event or Problem Description
New information received notes that the physician decided that no intervention will be made since the patient never received any therapies from the device and the lead.The patient was stable.

• Brand Name: DURATA STS OPTIM PASSIVE FIXATION
• Common Device Name: DEFIBRILLATION LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 8485020
• Report Number: 2017865-2019-04997
• Device Sequence Number: 1783964
• Product Code: LWS
• UDI-Device Identifier: 05414734502443
• UDI-Public: 05414734502443
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2019

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: 06/04/2012
• Device Model Number: 7171/65
• Device Lot Number: 2915304
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 05/02/2019; 09/19/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 05/02/2019; 09/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR