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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/22/2015

Event Type  malfunction  

Event Description

It was reported by a physician that a patient's vns showed high lead impedance on diagnostics at a clinic visit.Additional relevant information has not been received to-date.No known surgical intervention has occurred to-date.

Event Description

Follow-up to the physician revealed a chest x-ray was taken and showed that the device migrated down near the left breast and medial to the original location.The x-rays were not sent to the manufacturer for review.The patient reported the migration had occurred over the past three years.The patient reported pain due to the migration which was explained by the physician as mechanical from the patient's bra rubbing on the unit.The last systems diagnostics in (b)(6) 2015 were reportedly fine.The physician did not know whether the sutures were non-absorbable or the relationship of the sutures to the migration.It was reported the patient has not had any significant changes in weight.The physician believes that the high impedance and the migration are related and that the high impedance is the result of the migration of the generator.The device was not turned off, and the settings were not changed.

Event Description

Operative notes for the implant surgery were received and indicated that a stitch was used to secure the generator, but the type of suture was not indicated.For the lead, two loops were formed and were stated to be secured with stitches.The type of suture used to secure the loops of the lead was not indicated.

Event Description

Clinic notes from a visit on (b)(6) 2016 were received providing that the patient had her generator disabled on (b)(6) 2016 due to discomfort, however she experienced an increase in frequency and more violent seizures since it was turned off.The patient had the device turned back on (b)(6) 2016.Diagnostics on (b)(6) 2016 showed high lead impedance.Follow-up to the physician revealed that the additional discomfort was experienced in the neck due to stimulation and resolved after the device was turned off.The pain at the chest was specified to be in the left superior chest and did not resolve after the device was turned off.Re-enabling the device did not resolve the increase in seizures.

Event Description

An implant card was received 05/24/2016 indicating the generator was replaced prophylactically and the lead was replaced due to lead discontinuity.The explanted devices were reported to have been discarded and are unable to be returned for analysis.

• 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: 5237219
• MDR Text Key: 31938346
• Report Number: 1644487-2015-06488
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2010
• Device Model Number: 302-20
• Device Lot Number: 200673
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/22/2015
• Initial Date FDA Received: 11/19/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/18/2015; 02/04/2016; 04/10/2016; 06/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2007
• 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): Required Intervention
• Patient Age: 60 YR