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 Unspecified Infection (1930); Tissue Breakdown (2681)

Event Date 01/16/2018

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.

Event Description

It was reported that the patient had vns generator and lead explant surgery due to infection shortly after the patient had generator replacement surgery.The patient then required another surgery several months later due to an extruding tie-down.The surgeon removed the extruding tie-down, a tie-down that was covered in fibrous tissue, and sutures from the lead area.The surgeon reportedly did not know the cause of the tie-down extrusion or infection.The device history records of the generator and lead were reviewed, and both devices were sterilized according to procedure prior to release.No further relevant information has been received to date.

Event Description

The patient's sister reported to the physician that the patient's device was exposed due to the patient picking at his vns site.No further 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: 7281537
• MDR Text Key: 100401850
• Report Number: 1644487-2018-00244
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/21/2018
• Device Model Number: 106
• Device Lot Number: 204262
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/04/2017
• 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: 30 YR