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

Device Problem High impedance (1291)

Patient Problem Pain (1994)

Event Date 06/26/2015

Event Type  malfunction  

Event Description

It was reported that the patient reported having painful stimulation in the neck after walking in front of an mri suite with the door to the magnet open.Thus, the manufacturer's sales representative interrogated the patient's device and completed a diagnostic test which revealed high impedance on the patient's vns system.Two more diagnostic tests revealed normal impedance following the initial high impedance result.The patient's device settings were subsequently lowered but the patient continued to experience the painful stimulation, this time in the chest pocket.Thus, the patient's device was programmed off.The pain in the patient's neck returned following the device being programmed back on (b)(6) 2015, characterized as a pulling sensation in the left neck and ear.Thus, the device was again turned off, with only magnet mode current remaining on.Device diagnostics were run again which revealed normal impedance.X-rays were reviewed by the neurologist which showed the vns leads were intact.There has been no reported trauma or manipulation.The physician does not know how this high impedance event began occurring.No known surgical interventions have been performed to date.

Event Description

Additional programming history was received and reviewed.The data obtained shows programming events from the date of the event, (b)(6) 2015, as well as a follow up visit with the treating physician on (b)(6) 2015.On (b)(6) 2015, the patient came in with the device disabled and left with device disabled as well.System diagnostic performed on (b)(6) 2015 resulted in normal impedance.The internal data decoded from the vns generator was reviewed as well.The data shows that impedance changed from 2356 ohms to 21822 ohms on (b)(6) 2015 from a 24-hour impedance measurement.System diagnostics performed later on (b)(6) 2015 showed an impedance change from 21822 ohms to 2089 ohms.Thus, the high impedance appears to have appeared and resolved all on (b)(6) 2015.No additional relevant information has been obtained to date.

• Brand Name: LEAD MODEL UNKNOWN
• 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: 4936447
• MDR Text Key: 22780275
• Report Number: 1644487-2015-05250
• 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: company representative,health
• Reporter Occupation: Other
• Report Date: 06/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 09/23/2015
• 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 Age: 42 YR