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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 304

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CYBERONICS - HOUSTON LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problem Fracture
Event Date 11/01/2017
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was reported that during diagnostic testing, high impedance was observed on the patient's vns. It was reported that there was no recent trauma to the area. Clinic notes were later received indicating that the patient strongly declined the disablement of the vns. The patient was referred for vns lead replacement surgery. No relevant surgical intervention is known to have occurred to date. No additional relevant information has been received to date.

 
Event Description

It was later reported the patient was experiencing severe abdominal pain and was wondering if it was related to the vns leads and the high impedance. The patient presented to the physician's office due to the pain. No additional relevant information has been received to date.

 
Event Description

The patient underwent full vns replacement surgery. During attempts at product return, it was revealed that the facility, historically, does not return explanted devices and had discarded the products.

 
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Brand NameLEAD MODEL 304
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 Key7046309
Report Number1644487-2017-04837
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 02/01/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/20/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/23/2016
Device MODEL Number304-20
Device LOT Number202997
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/22/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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