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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD Back to Search Results
Model Number 7120Q/58
Device Problems Helifix Coil (567); Retraction Problem (1536)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/12/2020
Event Type  Malfunction  
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

It was reported that during initial implant, the right ventricular lead helix would not extend during device preparation. The lead was replaced. There were no patient consequences.

 
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Brand NameDURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
Type of DeviceDEFIBRILLATION LEAD
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer Contact
sonali arangil
15900 valley view court
sylmar, CA 91342
MDR Report Key10216164
MDR Text Key197081729
Report Number2017865-2020-08439
Device Sequence Number1
Product Code NVY
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberP950022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/18/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/30/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2020
Device MODEL Number7120Q/58
Device Catalogue Number7120Q-58
Device LOT NumberA000043701
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/30/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/29/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/05/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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