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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 01/01/2008
Event Type  Malfunction  
Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
Event Description

It was reported that vns pt had generator replacement due to normal end of service. When the new generator was attached to the lead during surgery, they received high impedance. Surgeon tried re-inserting the pin three times and they were sure the pin was fully inserted, but they still received high impedance. Surgeon then decided to replace the lead. When he opened the neck site to expose the vagus nerve he reported, "the electrodes were broken and looked like they had been snapped off of the nerve. " they ran system diagnostics with the new lead and everything was within normal limits. Attempts for further info are in progress. Product analysis is pending on the generator and lead.

 
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Brand NameLEAD MODEL 302
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
michael carroll
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1096205
Report Number1644487-2008-01742
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/03/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/31/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2004
Device MODEL Number302-20
Device LOT Number7195
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer07/23/2008
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/03/2008
Was Device Evaluated By Manufacturer? No
Date Device Manufactured10/01/2002
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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