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

Model Number 302-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscle Spasm(s) (1966); Neck Pain (2433); Fibrosis (3167); No Code Available (3191)

Event Date 04/01/2015

Event Type  Injury  

Event Description

It was reported that the patient had issues with a lead pulling sensation.The patient had a revision surgery to loosen up the lead for more range of motion for the patient and it was noted that the patient had fibrosis around the lead.No additional relevant information has been received to date.

Manufacturer Narrative

Describe event or problem - corrected information: the information included in describe event or problem on this report should have been included in the initial report as the surgery for the patient was due to the all of the adverse events reported for the patient.Relevant tests/laboratory data - corrected information: the settings and diagnostic data should have been included in the initial report.(b)(4).

Event Description

Information should have been included in the initial report that the patient also had painful stimulation and muscle spasms in the neck at the electrode site.The spasms in the patient's neck subsided when the vns magnet was placed over the generator to disable it.The patient's settings were adjusted multiple times and the normal and systems diagnostics were stated to be ok.The painful stimulation and muscle spasms were stated to not have resolved after the surgery to reposition the lead indicating that the surgery could have been to help alleviate those adverse events as well.

• 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: 7155729
• MDR Text Key: 96108538
• Report Number: 1644487-2017-05096
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/10/2018

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2017
• Device Model Number: 302-20
• Device Lot Number: 202560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 12/29/2017
• Supplement Dates Manufacturer Received: 01/10/2018
• Supplement Dates FDA Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 48 YR