MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 302

Model Number 302-20

Device Problem High impedance (1291)

Patient Problems Pain (1994); Neck Pain (2433)

Event Date 11/18/2013

Event Type  malfunction  

Event Description

On (b)(6) 2013, it was reported that the patient would have a vns replacement due to high impedance.Follow up found that replacement surgery was for patient comfort and they were not concerned with it resulting in a serious injury.Previously, the patient reported experiencing pain with stimulation which was felt at the neck and travelled up to the left ear.It was confirmed at the time that no trauma, manipulation, programming changes, or medication changes had occurred recently.The patient's settings were originally at 2.5ma and 2.75ma for normal and magnet output current respectively.The output currents were reducted to 0.25ma and 0.5 ma respectively.Diagnostics taken on this day, (b)(6) 2013, were all ok.X-rays were sent to the manufacturer for review.The generator was seen in the left chest area in normal orientation.The filter feedthru wires were intact and the lead pin could be seen past the second connector block indicating that it is fully inserted into the generator.A portion of the lead appears to be present behind the generator.The lead could not be assessed at the connector pin due to the x-ray image quality.The electrodes were observed in the neck and appear to be in proper alignment.A strain relief bend was present; however, no strain relief loop appeared to be present.There was one tie-down present.Lead is seen routing down toward the generator.No other information has been provided.Surgery is likely, but has not occurred to date.Received a phone call on (b)(6) 2013 from tc (b)(6) who stated that patient (b)(6) is experiencing painful stimulation which is felt at the neck and travels up to the left ear.He stated that he met with the patient yesterday, and the patient confirmed this has been occurring since monday ((b)(6) 2013).It had been confirmed that no trauma/manipulation/programming changes/medication changes had occurred recently.The patient¿s settings were originally 2.5ma for output current and 2.75ma for magnet output current, and the settings were decreased all the way down and the event was still occurring at 0.25ma/0.5ma.The physician decided to turn the device off and order x-rays.Diagnostics were all ok per tc.I stated that since diagnostics are ok x-rays are typically not recommended since the system appears to be fully intact.Tc insisted that the x-rays may show something and stated that he will be sending these x-rays to cts for review.He stated that he specifically wants these x-rays to be reviewed for a hairline fracture or fluid in the lead.I stated that this is very detailed and that it all depends on the images that are received.Tc inquired about other recommendations for this situation.I stated that it may be helpful to evaluate the patient after it has been disabled and for the physician to observe the patient after turning it back on.I inquired what the physician¿s assessment of this is and he stated the physician does not know.Tc stated they might undergo a full revision if nothing is found to help.I stated that this would be a medical decision which is up to the physician.No further information was discussed.

Manufacturer Narrative

Device manufacturing records and programming history were reviewed.Review of manufacturing records confirmed the device met all final testing specifications prior to distribution.Device failure is suspected, but did not cause or contribute to a death or serious injury.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS INC; 100 cyberonics blvd; houston TX 77058
• 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: 3562083
• MDR Text Key: 16221182
• Report Number: 1644487-2014-00120
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/11/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/17/2011
• Device Model Number: 302-20
• Device Lot Number: 1985
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/11/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2008
• 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 Age: 48 YR