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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 302

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LIVANOVA USA, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/07/2018
Event Type  Injury  
Event Description

It was reported that the patient had exploratory surgery due to a mass on the left side of the neck at the electrode site. The attending company representative indicated that the surgeon initially thought that the mass was related to the vns lead; the company representative thought that after the surgery the doctor did not think that the mass was related to the vns, but was not sure. No further relevant information has been received to date.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
LIVANOVA USA, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
LIVANOVA USA, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8122199
Report Number1644487-2018-02175
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 12/19/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/01/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/03/2004
Device MODEL Number302-20
Device LOT Number7109
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/19/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2002
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/01/2018 Patient Sequence Number: 1
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