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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
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was reported the patient needed to be scheduled for a full vns revision due to high impedance. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

It was later reported the patient underwent full revision surgery on (b)(6) 2016. It was noted the patient had to be implanted on the right side as there was too much scar tissue and too many electrodes and anchor tethers on the left vagus nerve and there was no more room for an additional implant. It was noted the generator was replaced due to neos = yes (near end of service) and that the lead was replaced due to the high impedance observed. After the new generator and lead were replaced, the diagnostics were confirmed as ok. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

Additional information was received noting the devices were discarded after surgery. Therefore, the devices are not expected for return and no analysis will be performed.

 
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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 Key5857766
Report Number1644487-2016-01787
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Followup,Followup
Report Date 07/12/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/09/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2013
Device MODEL Number302-20
Device LOT Number2478
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/15/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/20/2009
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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