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

Model Number 304-20

Device Problem Fracture (1260)

Patient Problems Chest Pain (1776); Hypoesthesia (2352)

Event Date 02/28/2017

Event Type  malfunction  

Event Description

It was reported by a patient that he was experiencing painful stimulation near the generator site and was told by the physician that the lead might be broken.The generator was turned off.Follow-up from the physician provided that diagnostics within normal limits on (b)(6) 2017.The patient had since had a fall and was in the er and had some chiropractic manipulation.The patient has been scheduled for surgical consult.Clinic notes from a visit on (b)(6) 2017 were received which provide the patient experiences discomfort and tingling at the generator site with electrical stimulation, but has not had any seizures.The lead impedance was noted to be high.Additional relevant information has not been received to-date.No known surgery has occurred to-date.

Event Description

Patient underwent lead replacement surgery.The explanted lead has not been received to date.

• 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: 6434933
• MDR Text Key: 70870742
• Report Number: 1644487-2017-03472
• 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: Patient
• Type of Report: Initial,Followup
• Report Date: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2017
• Is this an Adverse Event Report?: Yes
• 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?: No
• Event Location: Other
• Date Manufacturer Received: 06/28/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 27 YR