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

Model Number 7122/65

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Endocarditis (1834); Unspecified Infection (1930); Complaint, Ill-Defined (2331)

Event Type  Injury  

Manufacturer Narrative

This product is registered as a combination product.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

Manufacturing reference number - 2017865-2020-09430.Manufacturing reference number - 2017865-2020-09431.Manufacturing reference number - 2017865-2020-09432.It was reported that a symptomatic patient presented in the clinic with systemic infection and endocarditis; vegetation growth was noted on the leads.The entire system including the implantable cardioverter defibrillator, the right atrial, right ventricle and left ventricle leads was explanted.The patient was in stable condition before, during and after the procedure.

Manufacturer Narrative

Analysis was normal.No anomalies were found.

• Brand Name: DURATA STS OPTIM ACTIVE 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: 10297675
• MDR Text Key: 199549413
• Report Number: 2017865-2020-09437
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 05414734502153
• UDI-Public: 05414734502153
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2012
• Device Model Number: 7122/65
• Device Catalogue Number: 7122-65
• Device Lot Number: 2819581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: QUICKFLEX MICRO LV LEAD; TENDRIL ST; UNIFY ASSURA CRT-D RF HV; QUICKFLEX MICRO LV LEAD; TENDRIL ST; UNIFY ASSURA CRT-D RF HV
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR