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 Problem Unspecified Infection (1930)

Event Date 07/06/2016

Event Type  Injury  

Event Description

It was reported that a patient had a significant infection at her vns site shortly after implant.The infection was treated with antibiotics and got better, but the patient presented later with drainage from her vns site and signs of infection.Cultures were performed, and the patient was referred to the surgeon.The device history records of the generator and lead were reviewed, and both devices were sterilized prior to release.No further relevant information has been received to date.

Manufacturer Narrative

Device evaluated by mfr? no.Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.

Event Description

Additional information was received that the patient underwent generator replacement surgery.The generator was replaced because patient's skin at generator site eroded and the generator was exposed.The surgeon removed it from the pocket on the left side and implanted the new generator on the right side.The explanted generator was discarded.According to the neurologist, the infection was ongoing.It would clear up for sometime and then come back.Based on that he made decision to replace the generator and move pocket to right side of her chest.

• 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: 6193059
• MDR Text Key: 62952768
• Report Number: 1644487-2016-02926
• 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
• Report Date: 12/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/13/2018
• Device Model Number: 106
• Device Lot Number: 203782
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/05/2016
• 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: 54 YR