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

Model Number 7170/65

Device Problems Failure to Sense (1559); Device Sensing Problem (2917); Impedance Problem (2950)

Patient Problem Ventricular Fibrillation (2130)

Event Date 05/07/2020

Event Type  malfunction  

Manufacturer Narrative

This product is registered as a combination product.The results/method and conclusion codes along with investigation results will be provided in the final report.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 Description

It was reported that the patient presented for implant procedure on (b)(6) 2020.It was noted that the patient has a ventricular fibrillation.During procedure, the lead was attempted to be implanted and it was indicated that the parameters of perception and impedance could not be measured.The right ventricular lead was not used and was replaced.The patient was discharged.

Event Description

New information received noted that the right ventricular lead exhibited loss of sensing.

Manufacturer Narrative

Analysis was normal.No anomalies were found.

• Brand Name: DURATA STS OPTIM PASSIVE FIXATION
• Type of Device: DEFIBRILLATION LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10090413
• MDR Text Key: 192143832
• Report Number: 2017865-2020-06621
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 05414734502436
• UDI-Public: 05414734502436
• Combination Product (y/n): N
• PMA/PMN Number: P950022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/16/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 7170/65
• Device Catalogue Number: 7170-65
• Device Lot Number: A000075793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/07/2020
• Initial Date FDA Received: 05/26/2020
• Supplement Dates Manufacturer Received: 05/27/2020; 07/01/2020
• Supplement Dates FDA Received: 05/28/2020; 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR