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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problem Device Operates Differently Than Expected
Event Date 10/05/2015
Event Type  Injury  
Manufacturer Narrative

 
Event Description

Clinic notes were received that indicated on a recent visit on (b)(6) 2015 the patient complained that she was feeling tingling in her left neck, left elbow, and left little finger. She had her vns turned off because of these symptoms. The patient requested removal of the vns. Additional clinic notes were received which indicate that the patient feels the vns is not working for her. The patient reported numbness to the arm and feels like it is on fire. Good faith attempts for further information from the physician have been unsuccessful to date. Although surgery is likely, it has not occurred to date.

 
Manufacturer Narrative

(b)(4). Inadvertently did not include the udi on the initial report.

 
Event Description

On (b)(6) 2016 it was reported that the patient underwent explant of the vns on (b)(6) 2015. The explanted device was requested to be returned for product analysis but it was discarded by the hospital.

 
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Brand NameLEAD MODEL 304
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 Key5239410
Report Number1644487-2015-06504
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 10/27/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/20/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/15/2018
Device MODEL Number304-20
Device LOT Number4111
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/04/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/20/2014
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: 11/20/2015 Patient Sequence Number: 1
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