MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

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

Patient Problems Wound Dehiscence (1154); Death (1802); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); No Code Available (3191)

Event Date 01/01/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

The patient was scheduled to undergo a replacement surgery.During the replacement surgery the surgeon found that the patient¿s generator had migrated further than the neurosurgeon had anticipated and so he explanted the patient¿s vns in order to allow the pocket to heal.Cultures were taken at the time of the patient¿s surgery to determine if an infection was present.Follow up with the surgeon¿s office indicated that the cultures confirmed infection and that there was skin dehiscence, wound breakdown, and pus observed when the physician opened the patient.The surgeon also noted that the was a bit of trauma that had occurred to the patient¿s skin recently.The patient was discharged after surgery but then came back to the hospital later that day because she was not feeling well.Ten (10) minutes after returning to the hospital the patient went into cardiac arrest where she was placed on life support.The patient¿s organs then began shutting down and the patient passed away.The neurologist ¿s notes were reviewed and there was no mention of attributing the death to vns therapy.The patient's explanted generator has been received and is undergoing product analysis.The surgeon also indicated that he did not use a non absorbable suture to anchor the patient's generator in the subcutaneous pocket.A design history record review found that the patient's generator was sterilized prior to leaving the manufacturing facility.No other relevant information has been received to date.

Event Description

The patient was admitted to the hospital on (b)(6) 2017 due to increased seizures frequency and feeding intolerance.The patient had her medications were increased before the decision was made to induce coma.The patient was trialed on an anesthetic but developed a diffuse reaction, so she was then started on propofol infusion.On (b)(6) 2017 the patient developed severe acidosis and hypotension that resulted in cardiac arrest.The patient was then placed on life support where her kidneys began shutting down.The physician then attempted to improve the patient's electrolytes to help her heart cardiovert.However two attempts failed to cardiovert the patient.An electrophysiologist verified that the patent's heart would not likely recover.The patient's family then elected to remove the patient from life support.The explanted lead and generator were received for product analysis.Migration, wound dehiscence and infection are outside of the scope of product analysis.No anomalies were found with the generator that affected its functionality.Only a portion of the lead was returned and there was no noted discontinuity in the lead.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• 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: 6292580
• MDR Text Key: 66242916
• Report Number: 1644487-2017-03107
• 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
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2014
• Device Model Number: 103
• Device Lot Number: 202360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2013
• 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): Death; Required Intervention
• Patient Age: 13 YR