MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

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

Patient Problems Pain (1994); Discomfort (2330)

Event Date 09/21/2015

Event Type  Injury  

Event Description

It was reported that a patient experienced coughing, pain and, gagging when the magnet was swiped at the higher setting.The patient was reported to tolerate normal mode settings.The device was turned off as the physician thought there might have been a lead issue.The last systems diagnostics were on (b)(6) 2015 and were within normal limits.Follow-up by the company representative revealed that the patient first reported the symptoms on (b)(6) 2015 and later tolerated all settings on (b)(6) 2015.On (b)(6) 2015 she tolerated normal mode, but not the magnet mode.X-rays were taken and it was stated that the physician did not see any issues in the x-rays.The x-rays have not been received by the manufacturer for review to-date.Additional follow-up by the company representative to the physician revealed that the patient had a laryngoscopy in the summer of 2015, and the neurologist believed the procedure may have disrupted the lead, and caused the patient's symptoms.The issues were reported to have resolved after turning off the device.The company representative reviewed diagnostics from the physician's handheld and the results were reported to be normal.The patient scheduled an appointment with the surgeon and had the lead and generator replaced (b)(6) 2015.The generator was reported to have been replaced prophylactically along with the lead and no issues were suspected with the generator.The choice by the patient to request revision of the device was stated to be due to the pain and discomfort.Additional follow-up to the physician's office revealed the lead was decided to be replaced from a visit with their office at the beginning of (b)(6).It was reported by the staff that the surgery was due to malfunction of the lead wire, but additional information regarding the malfunction was not provided.It was reported that diagnostics were not recorded in the notes from the patient's next visit before the surgery.No additional relevant information has been received to-date.The explanted devices have not been received for analysis to-date.

Event Description

It was reported that the explanted products were discarded by the surgical facility.

• Brand Name: PULSE GEN MODEL 105
• Type of Device: GENERATOR
• 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: 5434813
• MDR Text Key: 38204815
• Report Number: 1644487-2016-00296
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2015
• Device Model Number: 105
• Device Lot Number: 3763
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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: 33 YR