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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 Date 05/01/2016
Event Type  Malfunction  
Event Description

It was reported that vns patient has increased in seizure frequency and does not feel the stimulation anymore. Vns system was checked and high lead impedance was found on both normal mode and system diagnostics. Xrays were taken and reviewed by the manufacturer. No obvious cause of the high impedance was observed on the xrays images. The generator is placed in a normal position in the upper left chest. The filter feed-through wires appeared to be intact. Lead connector pin seems to be fully inserted. The lead wires at the connector pin appeared to be intact. Portions of the lead appeared to be behind the generator and could not be fully assessed. No acute angles, no breaks were found in the parts of the lead that could be assessed. Review of manufacturing records confirmed all tests passed for the lead prior to distribution. No known surgical interventions have occurred to date.

 
Event Description

Additional information received that the lead has been successfully replaced on (b)(6) 2016. It was reported that during explant procedure, the surgeon "nicked" patient's carotid artery and decided to not remove the coils of the lead. The explanted lead is not expected to be returned for analysis. No patient trauma or manipulations have been reported. The reported increase in seizures was first noticed (b)(6) 2016.

 
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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 Key5797793
Report Number1644487-2016-01595
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup
Report Date 07/15/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/15/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2017
Device MODEL Number302-20
Device LOT Number202614
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/18/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/13/2013
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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