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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 Problems Detachment Of Device Component; High impedance
Event Date 10/18/2017
Event Type  Malfunction  
Event Description

It was reported that high impedance was detected on the patient's device through both normal mode diagnostics and system diagnostics. Follow-up with the physician found that the patient's lead wire had reportedly dislodged and the patient was experiencing a burning pain in their neck. The patient was also experiencing an increase in auras. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

 
Event Description

The treating neurologist indicated that they believed that the wire was dislodged because they could palpate it in the subcutaneous tissue. The patient's lead and generator were replaced. Product return is not expected. The replacement operative notes indicated that there was significant scar tissue in the patient's neck and it was unclear if a portion or the electrode was actually around the nerve. No further relevant information has been received to date.

 
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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 Key7023835
Report Number1644487-2017-04766
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 12/08/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/13/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2016
Device MODEL Number304-20
Device LOT Number3326
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/13/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/02/2012
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: 11/13/2017 Patient Sequence Number: 1
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