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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
Event Date 03/06/2015
Event Type  Injury  
Event Description

It was reported that a patient with a partially explanted vns system (approximately 6 cm of lead remaining implanted) experienced a hot, painful sensation in the left side of the neck and was getting stuffy while having an mri performed on (b)(6) 2015. The scan was interrupted but then started back up again. After the mri was completed, the patient was hoarse and experienced coughing and choking for the next few days. The neurologist couldn¿t find anything that could be contributing to these events. The patient had an ent evaluation where it was found that the patient had decreased sensitivity of the larynx however; the vocal cord movements were intact. The ent evaluation was performed on (b)(6) 2015. It was concluded that there was significant heating of the vagus nerve during the mri. Follow-up revealed that the scan was performed according to the new vns guidelines however, the ¿old¿ low sar epilepsy protocol was followed. The gradients are increased quickly which may be the cause of the issues the patient experienced. The physician indicated there was a stimulation of the vagus nerve because a stream is going to run in the remaining leads under the influence of rapid changes in the diffusion gradient despite the short duration of the series (approximately 1 minute). It is suspected that perhaps the spatial gradient field may have exceeded 720 gauss/cm. No additional relevant information has been received to date.

 
Manufacturer Narrative

 
Event Description

X-rays images were received by the manufacturer. Review of the images revealed a 6cm portion including the electrodes still implanted in the patient. Further information was later received indicating that the facility uses an mri rx/tx head coil which has been successfully used on vns patients previously.

 
Manufacturer Narrative

Evaluation codes; corrected data: the previously submitted mdr inadvertently lacked the required evaluation codes. Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4757324
Report Number1644487-2015-04644
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/14/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/07/2015
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
Event Location Other
Date Manufacturer Received06/05/2015
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

Patient TREATMENT DATA
Date Received: 05/07/2015 Patient Sequence Number: 1
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