MAUDE Adverse Event Report: CYBERONICS - HOUSTON 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 04/03/2019

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary as the extrusion and infection are not related to the functionality or delivery of therapy of the device.

Event Description

A nurse reported a patient's vns explant due to device extrusion.The nurse reported that the patient had been picking at the generator site, which led to generator exposure.It was assessed that patient manipulation/picking was the only contributory cause of the generator extrusion.Infection has not been confirmed at the site; however, there is suspicion of a possible infection at the generator site related to the patient picking open their incision for the past 6 months.A review of device history records showed that both the lead and generator were sterilized prior to distribution.Additionally, no unresolved non-conformances were found, and the device met all specifications for release prior to distribution.The generator and part of the lead were explanted.It was confirmed that no replacement is planned at this time.Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 9247557
• MDR Text Key: 164853328
• Report Number: 1644487-2019-02073
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/04/2020
• Device Model Number: 106
• Device Lot Number: 204637
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/03/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/19/2018
• 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: 24 YR