MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Device Problem Insufficient Information (3190)

Patient Problems Burning Sensation (2146); Respiratory Tract Infection (2420); Choking (2464); Decreased Sensitivity (2683)

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.

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.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• 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 Key: 4757324
• MDR Text Key: 5887868
• Report Number: 1644487-2015-04644
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• 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 Received: 05/07/2015
• 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 Received: 06/05/2015
• 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 Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR