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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  
Event Description

It was reported to manufacturer that the patient began experiencing painful stimulation at the neck and an increase in seizure activity, below pre-vns baseline. The patient was seen for follow up due to the recent events, and high lead impedance resulted from a system diagnostics test. No x-rays were taken to assess the continuity of the system. The patient subsequently had revision surgery to replace the problematic lead and replace the generator prophylactically. Further follow up with the explanting facility revealed that the explanted devices were discarded following the surgery.

 
Manufacturer Narrative

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

 
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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 Key1123852
Report Number1644487-2008-01906
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/16/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/15/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2008
Device MODEL Number302-20
Device LOT Number11652
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/16/2008
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2005
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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