MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

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

Patient Problems Erythema (1840); Unspecified Infection (1930)

Event Date 10/01/2016

Event Type  Injury  

Manufacturer Narrative

Suspect device udi: (b)(4).

Event Description

It was reported that the patient's following physician was unwilling to increase device settings because of redness over the generator site.It was suspected that the redness represented an infection.Attempts for additional pertinent information have been unsuccessful to date.

Event Description

Follow up with the treating neurologist showed that the patient was seen by their office in both (b)(6) 2016.The dates of the appointments were before the patient¿s caregiver reported the alleged infection to the manufacturer.The generator site appeared shifted, raised, and red.However, their office did not have any indication of interventions.The surgeon was stated as to not see it as necessary to intervene by moving the generator.Communications with the office of the surgeon showed the patient was seen in (b)(6) for a post-implant surgery evaluation between the two neurologist office visits.The surgeon has noted that the battery had moved inferiorly, but did not note any kind of infection or site reaction.The surgeon also commented that the wound appeared to be healing well, and there was no consideration of performing interventions at that time.

Event Description

Clinic notes were received indicating surgery to drain the cyst occurred.It was provided the patient has had more than one infection at the vns battery and lead sites.The physician provided that the infection was coming from the vns lead.The explanted remains of the lead and the generator were removed.Review of the manufacturing records for the lead and generator confirmed the devices were sterilized prior to distribution.

Manufacturer Narrative

(b)(4).

Event Description

Analysis was completed for the returned generator and lead.The generator performed according to functional specifications and no abnormal performance or any other type of adverse condition was found.Other than typical wear and explant related observations, no anomalies were identified in the returned lead portions.

Event Description

The explanted devices were received by the manufacturer.Analysis is underway, but has not been completed to-date.

• Brand Name: PULSE GEN MODEL 102
• 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: 6097070
• MDR Text Key: 59770140
• Report Number: 1644487-2016-02625
• 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: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/14/2017
• Device Model Number: 102
• Device Lot Number: 203273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2017
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2015
• 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
• Patient Age: 18 YR