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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/30/2005
Event Type  Injury  
Manufacturer Narrative

Device evaluation is not necessary as the event has been attributed to the placement/surgery for the vns and is not related to the functionality or delivery of therapy of the device.

 
Event Description

It was reported that the patient had complained of hoarseness uncorrelated with generator ¿on¿. The patient said that it had been worse the ¿last several years¿. This hoarseness had been present since the patient was first implanted. The surgeon believed it was likely due to the low placement of the first lead implanted because it was close to the vocal cords. The surgeon thought that the patient may have vocal cord paralysis. It was also possible that the patient was just old. No known surgical interventions have occurred to date. No further relevant information has been received to date.

 
Event Description

It was reported by the surgeon's office that vocal cord paralysis was not verified. No further relevant information has been received to date.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7376026
Report Number1644487-2018-00471
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 05/11/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/27/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2008
Device MODEL Number302-20
Device LOT Number1102
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/17/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/18/2005
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: 03/27/2018 Patient Sequence Number: 1
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