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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 01/01/2008
Event Type  Injury  
Event Description

It was reported that the patient's generator and lead would be explanted due to lack of efficacy. The patient was explanted. While following up with the office, the nurse read from the clinic notes that the patient was explanted because they had no clear benefit from the vns, the vns was causing the patient pain in the neck, and the device was turned off. The nurse could not clarify whether the explant was due to patient pain or just for lack of efficacy. The suspect product has not been received to date. No further relevant information has been received to date.

 
Manufacturer Narrative

Device available for evaluation?, corrected data: the initial report inadvertently omitted that the products were received. Describe event or problem, corrected data: the initial report inadvertently omitted that the products were received.

 
Event Description

It was reported by the physician that the patient's pain in neck was not the reason for explant. The pain reported was painful stimulation for which the patient's vns was disabled in 2010 for patient comfort. The explanted lead and generator were received. Product analysis was completed on the returned lead portion. The electrodes and part of the lead body were not returned so could not be evaluated. Product analysis identified an abraded opening in the lead outer tubing that caused fluid leaks into the outer tubing. However, product analysis found no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the patient's painful stimulation. The lead performed according to functional specifications with no obvious anomalies identified. Product analysis has not been completed on the returned generator, to date. No further relevant information has been received to date.

 
Event Description

Product analysis was completed on the returned generator. The generator was monitored for 24 hours in a simulated body temperature environment. The generator provided the intended output current for the entirety of the monitoring period. A comprehensive electrical evaluation showed that the device performed according to functional specifications. No anomalies were identified.

 
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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 Key7042545
Report Number1644487-2017-04806
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 01/11/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/17/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/14/2005
Device MODEL Number302-20
Device LOT Number9771
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/16/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/21/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/16/2003
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: 11/17/2017 Patient Sequence Number: 1
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