MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

Model Number 304-20

Device Problem High impedance (1291)

Patient Problems Pain (1994); Seizures (2063); Dizziness (2194); Inadequate Pain Relief (2388); No Code Available (3191)

Event Date 01/01/2016

Event Type  malfunction  

Manufacturer Narrative

Event Description

High lead impedance was observed on system diagnostics for patient's device on (b)(6) 2016.Patient was referred for x-rays and surgery.Clinic notes from (b)(6) 2016 were received indicating that the patient has high lead impedance, and thus is being referred for lead and unit replacement.These clinic notes also indicate that the patient reports that in the last few months she no longer feels stimulation, especially with the magnet.Clinic notes from (b)(6) 2016 indicate that the patient has medically and surgically refractory partial onset seizures.Patient was referred to another physician to explore additional options to control her seizures as previous two left side epilepsy surgeries and vns have not helped her to control her seizures.Patient thinks increased stress level would cause her to have more seizures and her typical seizures now start with' dizziness ' followed by convulsions.Per the neurologist, patient had gotten benefit of seizure reduction with vns therapy compared to pre-vns baseline but not all of patient's seizures are controlled.No known surgical interventions have occurred to date.

Event Description

Clinic notes were received for patient's vns full revision referral.Per notes, the patient continues to not perceive vns stimulation and is having pain from the device when patient is sick.No known surgical interventions have occurred to date.

Event Description

Patient underwent full revision surgery.Prior to surgery, diagnostics were performed which resulted in high lead impedance with dcdc converter showing 7.We then tested the lead with the new 106 generator, it still resulted in high lead impedance.The surgeon cut the existing lead and placed the new lead.The surgeon indicated he did not see any visible defects on the lead.After completion of implant with new generator and lead, diagnostics were performed and the lead impedance was 924 ohms.Per operating room staff, the facility's process is to discard all explants.

• Brand Name: LEAD MODEL 304
• 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: 5975041
• MDR Text Key: 55899094
• Report Number: 1644487-2016-02183
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/19/2017

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: 01/31/2017
• Device Model Number: 304-20
• Device Lot Number: 3537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/30/2016
• Initial Date FDA Received: 09/23/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/09/2017; 05/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2013
• 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: 24 YR