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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

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CYBERONICS - HOUSTON LEAD MODEL 302 Back to Search Results
Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported by the patient that she wanted the vns lead removed due to high blood pressure. The vns generator was previously explanted to lack of efficacy, but the lead had remained implanted. The patient stated that she was experiencing baroreflex nerve damage and believed it to be due to the presence of the lead. The patient reported following up with physicians and all of the physicians believed that it was not related to the vns lead. The patient stated that this was only a recent issue and that she did not believe it was related to the surgery. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7819434
Report Number1644487-2018-01500
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 08/27/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/27/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2005
Device MODEL Number302-20
Device LOT Number8773
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/02/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/16/2003
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: 08/27/2018 Patient Sequence Number: 1
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