MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problems Failure to Anastomose (1028); Seroma (2069)

Event Date 08/17/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported by the physician that the mother believed the patient was having an issue with his incision site and wanted to get in touch with the surgeon.It was later explained that the patient was seen by the surgeon on (b)(6) 2016.The surgeon believed there was a possible seroma.The patient was put on antibiotics and was requested to come back in 2 weeks.On (b)(6) 2016 the surgeon noted that the antibiotics were resolving a possible lymphocele and he saw no strong indication to perform surgery and prescribed 1 more week of antibiotics.Additionally, it was explained that the patient's mother had apparently stuck a needle in the swelling before being seen by the surgeon.Review of the dhrs for both the lead and the generator confirmed sterilization prior to distribution.

Event Description

The physician noted concern regarding the issue with the patient's lymph tissue and referred the patient for neck site flushing.It is unknown if the flushing actually occurred.Attempts for additional relevant information have been unsuccessful to date.

Event Description

It was reported the patient was still having problems with infection.The patient was referred to the or to see if the vns would need to be explanted.It was noted the patient had infection before, close to the time of the implant, and it must have returned and there was some fluid build-up in the chest pocket.It was noted the patient had a full vns explant due to the infection.

• Brand Name: PULSE GEN MODEL 106
• 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: 5952395
• MDR Text Key: 54782732
• Report Number: 1644487-2016-02083
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/17/2017

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: 02/07/2017
• Device Model Number: 106
• Device Lot Number: 203476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/17/2016
• Initial Date FDA Received: 09/15/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/05/2016; 03/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2016
• 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: 5 YR