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

Model Number 106

Device Problem Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Purulent Discharge (1812); Unspecified Infection (1930)

Event Date 09/27/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient was having his vns generator explanted due to infection.Further follow-up found that the patient presented with purulent drainage at the generator site.The patient underwent a wound cleaning procedure for the infection however the surgeon then elected to remove the generator.The lead was cut and the portion of the lead with the electrodes was left implanted.Samples from the infection were sent to the microbiology lab however the results from the microbiology testing have not been received to date.Manufacturing records for the generator were reviewed and it was noted that it was sterilized prior to distribution.No additional relevant information has been received to date.

Manufacturer Narrative

Corrected data: evaluation codes: this information was inadvertently reported incorrectly on mfg.Report 0.

Event Description

It was reported that the patient had presented with a dehiscence wound several months after the device had been explanted due to infection.The wound had not completely healed and he was placing vaseline on the wound.No additional relevant information has been received to date.

• 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: 6053715
• MDR Text Key: 58295206
• Report Number: 1644487-2016-02463
• 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: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/03/2018
• Device Model Number: 106
• Device Lot Number: 203745
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2016
• 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: 49 YR