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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 03/24/2008
Event Type  Malfunction  
Event Description

Reporter indicated a vns patient's generator was explanted end of service. Prior to the battery depletion, the patient experienced erratic and painful stimulation in the neck. The patient elected not to have the device replaced. Prod analysis on the generator revealed no anomalies suggesting a malfunction with the lead. The lead was explanted; therefore, a prod analysis will not be performed. The surgeon did not note a malfunction with the lead during the surgery. Good faith attempts to obtain add'l info have been unsuccessful to date.

 
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Brand NameLEAD MODEL 302
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
michael carroll
100 cyberonics blvd.
suite 600
houston , TX 77058
2812287200
MDR Report Key1076767
Report Number1644487-2008-01587
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/10/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/11/2008
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 Number1490
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/10/2008
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2006
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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