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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 303

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CYBERONICS INC LEAD MODEL 303 Back to Search Results
Model Number 303-30
Event Date 09/15/2011
Event Type  Malfunction  
Event Description

Reporter indicated a patient had their vns generator and lead removed due to "shocking" sensations, lack of efficacy, and suspected damage to the vns lead due to a mri being performed. No new vns devices were implanted. The explanted devices will not be returned per hospital policy. Attempts for further information are in progress.

 
Event Description

Reporter indicated the patient's painful vns stimulation was experienced at the chest wall location. The patient had no known trauma and did not manipulate the vns. Vns diagnostics tests prior to explant of the device were within normal limits per the reporter. In addition, x-rays of the vns did not indicate any adverse findings or fractures. The reason for the explant of the vns was due to lack of efficacy per the reporter.

 
Event Description

All attempts for further information have been unsuccessful to date.

 
Manufacturer Narrative

Suspect medical device, corrected data: the incorrect lot number was inadvertently reported on the initial mdr report. The correct lot number is provided.

 
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Brand NameLEAD MODEL 303
Type of DeviceLEAD MODEL 303
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2317767
Report Number1644487-2011-02618
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/04/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/01/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2009
Device MODEL Number303-30
Device LOT Number200287
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/02/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/28/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/01/2011 Patient Sequence Number: 1
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