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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 High impedance
Event Date 03/09/2018
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was reported that a patient was scheduled to have his vns generator and leads explanted. Upon follow-up it was stated that the reason for explant was due to the vns device not helping. A fax response was received for further follow-up questions from the physician's office. The physician did not provided an assessment for the patient's lack of efficacy. The last programmed settings and diagnostics were provided. It was noted that impedance was high, though no value was provided. Device history records were reviewed for the generator and lead products. Both devices passed all quality inspections prior to distribution. No known surgery has occurred to date. No additional, relevant information was received to date.

 
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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
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8557239
Report Number1644487-2019-00805
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 04/26/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/26/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number304-20
Device LOT Number203998
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/11/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/12/2017
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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