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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 03/15/2007
Event Type  Malfunction  
Event Description

It was reported that a vns patient experienced cough and subsequent muscle spasms in the neck with vns stimulation. X-rays were taken and reviewed at manufacturer no anomalies were observed. The patient's treating physician did witness the muscle spasms and correlated it with stimulation cycles. The patient's device was disabled and both cough and muscle spasms resolved. There are no plans to turn on the device. As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the patient's device, this file was found to be possibly related to a short-circuit condition.

 
Manufacturer Narrative

Manufacturer review of x-rays. Results - x-rays reviewed by manufacturer, no gross lead discontinuities visualized. Conclusions - device malfunction suspected, but did not cause or contribute to a death or serious injury.

 
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Brand NameBIPOL LEAD MODEL 300
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1478433
Report Number1644487-2009-01402
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 06/08/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/02/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2002
Device MODEL Number300-20
Device LOT Number745
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/08/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2000
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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