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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 08/25/2009
Event Type  Malfunction  
Event Description

It was reported that the patient could feel constant vibration in her neck where the lead is starting on (b) (6) 2009 and felt there was something wrong with the lead. When the patient put the magnet over her device to stop stimulation, the vibration stopped. The patient secured the magnet over her device to stop stimulation. Attempts for further information have been unsuccessful to date.

 
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Brand NameLEAD MODEL 302
Manufacturer (Section D)
CYBERONICS INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
suite 600
houston , TX 77058
2812287200
MDR Report Key1507311
Report Number1644487-2009-02126
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/25/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/24/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2009
Device MODEL Number302-20
Device LOT Number200354
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/25/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2006
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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