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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL

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CYBERONICS, INC. PULSE GEN MODEL Back to Search Results
Event Date 08/01/2008
Event Type  Malfunction  
Event Description

Initial reporter indicated that the patient had been explanted for pain in the chest and neck area with vns therapy. Good faith attempts are being made for additional details surrounding the reported event.

 
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Brand NamePULSE GEN MODEL
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1181594
Report Number1644487-2008-02347
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/28/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/25/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/28/2008
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 09/25/2008 Patient Sequence Number: 1
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