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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problems Shock (2072); Tingling (2171)

Event Date 01/01/2014

Event Type  malfunction  

Event Description

It was reported that device diagnostics resulted in high impedance.It was reported that the patient had experienced a shocking sensation and the device was checked.The device was not programmed off after observing the high impedance.Clinic notes dated (b)(6) 2014 noted that the patient has experienced a shocking sensation on the left side of the neck for about the past 6 months.The notes indicate that the patient has parasthesias in the left neck radiating up to the left ear.The neurologist reported that the device was not at end of service and it was unknown if any patient manipulation or trauma occurred that could have contributed to the high impedance.The patient was referred to neurosurgeon.No known surgical intervention has been performed to date.

Manufacturer Narrative

Device failure suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.(b)(4).

Event Description

Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to high impedance.A pre-operative system diagnostic test showed high impedance (dc dc - 7).The replacement generator was first tested with the existing lead and system diagnostic results still showed high impedance (dc dc - 7).The surgeon then replaced the patient's lead and system diagnostic results showed lead impedance within normal limits.It was noted that the surgeon was unable to explant the electrodes of the lead due to scar tissue around the jugular vein.The patient's replacement device was not programmed on during the procedure.The explanted devices have not been returned to date.The patient stated that she began experiencing pain in her ear approximately six months prior to the initial report of the event.The pain had since moved to the chest and neck incisions sites.The patient was able to differentiate stimulation on-times and off-times and clarified that the pain was intermittent and did not only occur with stimulation on-times.No patient trauma was reported.

• 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: 3971704
• MDR Text Key: 4753290
• Report Number: 1644487-2014-01911
• 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,Followup
• Report Date: 07/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2009
• Device Model Number: 302-20
• Device Lot Number: 200104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2006
• 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: 46 YR