MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 102; LEAD

Model Number 304-20

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problems Twitching (2172); Neck Pain (2433)

Event Date 01/21/2016

Event Type  malfunction  

Manufacturer Narrative

Suspect device udi#: (b)(4).

Event Description

It was reported by the physician that the patient developed twitching in her neck with the use of the vns magnet.The physician suspects the twitching is due to a lead fracture and has advised the patient not to use the magnet as the patient has no other symptoms and the normal vns output current is not causing the same symptoms as magnet use.Settings were adjusted due to the discomfort with the magnet stimulation, which occurred prior to the observance of the muscle twitching.No settings were changed due to the reported muscle twitching.

Event Description

The patient underwent vns explant surgery.During attempts at product return, it was revealed that the facility, historically, does not return explanted products.

Manufacturer Narrative

Describe event or problem, corrected data: follow-up report #1 inadvertently left out information.(b)(4).

Event Description

Clinic notes were received by the manufacturer and indicated that the patient had difficulties with pain at the neck and chest where the vns was implanted.It was stated that she developed issues with tension at the neck when trying to do sit-ups.When the vns activated, she experienced contractions of the laryngeal musculature.The patient reported twitching in her neck muscles with magnet stimulation.The vns magnet mode was programmed off.It was stated that since the magnet mode was disabled, the patient was getting the warning for complex partial seizures for shorter lengths of time, which she did not get before.The operative notes from the initial implant were included and no complications were reported.It was noted that the lead was secured to the surrounding subcutaneous tissues with 4-0 sutures.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5453369
• MDR Text Key: 39269820
• Report Number: 1644487-2016-00388
• 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,Followup
• Report Date: 03/21/2018

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: 12/07/2018
• Device Model Number: 304-20
• Device Lot Number: 203196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/25/2016
• Initial Date FDA Received: 02/23/2016
• Supplement Dates Manufacturer Received: 02/25/2018; 03/21/2018
• Supplement Dates FDA Received: 03/19/2018; 03/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2014
• 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: 25 YR