MAUDE Adverse Event Report: CYBERONICS, INC. BIPOL LEAD MODEL 300

Model Number 300-20

Device Problems Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Date 06/25/2015

Event Type  malfunction  

Event Description

It was reported that the patient¿s device was turned off for mri on (b)(6) 2015, and turned back on on (b)(6) 2015.At this time the pulse width was increased from 250 to 500.Around 5:30 am on(b)(6) 2015, the patient could not speak or stick out her tongue, and appeared to be in much pain.Device was turned off again and it helped for a while but the issues did not resolve.System diagnostics show result of high impedance.It was also mentioned that the patient recently underwent craniotomy 3 days prior to (b)(6) 2015.

Manufacturer Narrative

Review of the available programming and diagnostic history.Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description

Additional information was received that the high impedance was first observed on (b)(6) 2015 and was not observed prior to that.Patient was referred for lead revision and prophylactic generator replacement but no surgical interventions have occurred to date.

Event Description

Additional information was received that the patient underwent surgery on (b)(6) 2015.It was reported that the patient's implanted generator and lead were not removed as the surgeon did not want to create a new scar.Instead, the surgeon implanted a new vns generator and lead on the right side of the patient.The lead was implanted on the right vagal nerve.The patient and family agreed with the surgeon and therefore the old devices were not touched.The surgeon was informed of the cardiac risks of implanting vns system on the right side.The neurologist was also made aware of the two systems implanted in patient and that the system on the left will show high impedance as this was not corrected.Neither the patient nor the surgeon at this time feels that it is necessary to remove the suspect device.

• Brand Name: BIPOL LEAD MODEL 300
• 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: 4907360
• MDR Text Key: 6029418
• Report Number: 1644487-2015-05166
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2004
• Device Model Number: 300-20
• Device Lot Number: 5131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 07/14/2015
• Initial Date FDA Received: 07/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2002
• 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: 58 YR