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

Model Number 304-20

Device Problem High impedance (1291)

Patient Problem Seizures (2063)

Event Date 02/06/2017

Event Type  malfunction  

Event Description

It was reported that a patient had high impedance on his vns system.The patient's generator had been replaced about three months prior to the reported high impedance.Clinic notes were received, and the high impedance was seen during interrogation and diagnostics.The patient had stopped feeling stimulation.X-rays were performed, but they were not released to the manufacturer.The device history records of the generator and lead were reviewed, and both devices conformed to all specifications prior to release.No further information has been received to date, and no known surgical intervention has occurred to date.

Event Description

The patient had lead revision surgery due to high impedance.The impedance was tested with the existing lead reinserted into the generator, but high impedance was still present.Therefore, the lead was replaced, and the high impedance resolved.The explanting facility discarded the lead.

• 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: 6377216
• MDR Text Key: 69045853
• Report Number: 1644487-2017-03311
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2017

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: 11/30/2017
• Device Model Number: 304-20
• Device Lot Number: 3788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/06/2017
• Initial Date FDA Received: 03/03/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2013
• 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: 37 YR