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 Type  malfunction  

Event Description

It was reported that vns patient has a lead revision surgery planned.Further clarification was obtained that the reason for the lead revision is high impedance, suspected lead break.The review of the manufacturing records confirmed all tests passed for the lead prior to the distribution.The available programming and diagnostic history reviewed by the manufacturer did not reveal any anomalies.Additional information was received that patient underwent lead revision surgery on (b)(6) 2016.

Manufacturer Narrative

Description of event; corrected data: the previously submitted mdr inadvertently provided an incorrect event description.Date of explant; corrected data: the previously submitted mdr inadvertently provided the wrong suspect device for the event.

Event Description

It was reported that vns patient has a lead revision surgery planned.Further clarification was obtained that the reason for the lead revision is high impedance, suspected lead break.The review of the manufacturing records confirmed all tests passed for the lead prior to the distribution.The available programming and diagnostic history reviewed by the manufacturer did not reveal any anomalies.Follow up with the physician indicated that the suspected lead has been not removed but they have just inserted another lead.The surgery occurred on (b)(6) 2016.The lead impedance returned to the normal value with the implant of the new lead.

• 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: 6101505
• MDR Text Key: 60430248
• Report Number: 1644487-2016-02604
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2010
• Device Model Number: 302-20
• Device Lot Number: 200462
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2007
• 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