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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) OPTISURE ACTIVE FIXATION; DEFIBRILLATION LEAD
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) OPTISURE ACTIVE FIXATION; DEFIBRILLATION LEAD Back to Search Results
Model Number LDA220/65
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event 02/01/2019
Type of Reportable Event Serious Injury
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 the patient developed pericardial tamponade after the a lead replacement procedure.The patient was treated and later discharged.No other complications were reported.
 
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Brand Name
OPTISURE ACTIVE FIXATION
Common Device Name
DEFIBRILLATION LEAD
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key8466912
Report Number2017865-2019-04703
Device Sequence Number16900719
Product Code NVY
UDI-Device Identifier05414734507202
UDI-Public05414734507202
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P950022
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/29/2019
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? No
Operator of Device Health Professional
Device Expiration Date09/30/2021
Device Model NumberLDA220/65
Device Lot NumberS000065663
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/18/2019
Initial Report FDA Received Date03/29/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Life Threatening; Required Intervention;
Patient Age67 YR
Patient Weight91
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