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

Model Number 102

Device Problem Insufficient Information (3190)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); Local Reaction (2035)

Event Date 02/09/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient experienced an infection and had some portion of her vns system explanted.Further information received indicated that the generator was explanted on (b)(6) 2016.When the patient presented, she had yellow drainage from her chest vns incision site.The generator device history record was reviewed and found that all specifications, including device sterilization, were met prior to distribution.Attempts for additional pertinent information have not been successful to date.

Event Description

It was reported that the patient's vns was fully removed, including the lead, in the previously reported explant surgery.Further details were provided on the nature of the infection.The wound was found to have a significant amount of pus.After removal, it was irrigated and associated necrotic tissue was removed prior to completion of the surgery.No additional pertinent information has been received to date.

Event Description

It was reported that the infection was due to an allergic reaction to latex.No further relevant information has been received 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: 5575238
• MDR Text Key: 42610016
• Report Number: 1644487-2016-00766
• 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,Followup
• Report Date: 03/30/2018

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: Health Professional
• Device Expiration Date: 10/27/2017
• Device Model Number: 102
• Device Lot Number: 4648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/21/2016
• Initial Date FDA Received: 04/13/2016
• Supplement Dates Manufacturer Received: Not provided; 03/06/2018
• Supplement Dates FDA Received: 07/20/2016; 03/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2015
• 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): Required Intervention
• Patient Age: 60 YR