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 Problem Unspecified Infection (1930)

Event Date 11/18/2014

Event Type  Injury  

Event Description

It was reported that the patient was scheduled for vns debridement.The patient had recent generator and lead replacement surgery on (b)(6) 2014.The surgeon¿s office reported that the patient had a post-operative infection.As a result, the plan was to debride and drain the spot on skin.The patient had surgery on (b)(6) 2015 to debride, and the patient was subsequently referred to the infectious disease doctor.

Event Description

It was reported that the patient was scheduled for re-implant surgery.However, surgery has not occurred to date.

Event Description

An implant card was received which reported that the patient was re-implanted with a vns therapy system.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of the manufacturing history records confirmed sterilization for both the generator and lead prior to distribution.

Event Description

The reimplanted vns system was placed on the left vagus nerve.

Event Description

It was reported that the patient was scheduled for revision surgery.The surgeon planned to remove the vns system due to the infection, let it heal for a couple of weeks, and then go back in and either place the generator on right with electrodes on left vagus nerve or completely re-implant the system on the right side anatomy.It was reported that during surgery on (b)(6) 2015, the surgeon nicked the jugular vein when trying to cut the lead with less than 2 cm remaining.The bleeding was controlled with the use of a clip that was inserted.The pocket site culture that was completed was positive for an infection.The plan was to treat the patient with antibiotics.It was reported that the patient first presented with a staph infection on (b)(6) 2015 with a fluid-filled chest pocket.The nurse was unsure if the neck incision was also infected at that time.Antibiotic bactrim was prescribed but not successful as the patient was unable to tolerate.The patient was seen again on (b)(6) 2015 and was referred to infectious disease.The patient was seen on (b)(6) 2015, and keflex was prescribed at that time.After the patient was seen by the surgeon on (b)(6) 2015 again, the decision was made to explant.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4476743
• MDR Text Key: 5567327
• Report Number: 1644487-2015-03736
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2016
• Device Model Number: 103
• Device Lot Number: 4029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2014
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 38 YR