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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. BIPOL LEAD MODEL 300

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CYBERONICS, INC. BIPOL LEAD MODEL 300 Back to Search Results
Model Number 300-20
Event Date 03/12/2007
Event Type  Malfunction  
Event Description

Reporter indicated a vns patient was experiencing painful stimulation in the neck and generator site and felt that the generator was pulling on the leads. Diagnostics were within normal limits. The device was programmed off at the request of the patient. X-rays were reviewed and no anomies were noted. The patient underwent generator replacement surgery. The lead was not replaced because the surgeon did not believe a problem existed with the generator. The patient's painful stimulation persists. The patient is planning on vns lead replacement surgery. The lead will be implanted on the right vagus nerve. Good faith attempts to obtain additional information have been unsuccessful to date.

 
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Brand NameBIPOL LEAD MODEL 300
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1297765
Report Number1644487-2008-02951
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/06/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/05/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number300-20
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received11/05/2008
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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