MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Neck Pain (2433); Tissue Breakdown (2681)

Event Date 10/27/2018

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr?, code 81: device evaluation is not necessary as infection and other adverse events are not related to the functionality or delivery of therapy of the device.(b)(4).

Event Description

It was reported that the patient was hospitalized due to an infection, which led to the removal of their vns generator and a wound debridement.The patient's neurologist indicated that the reason for the generator pocket infection was unknown.It was reported that prior to generator explant, the generator was visible, likely due to the infection per the physician, and that the patient had a history of wound dehiscence, generator migration, and erosion through the skin.The patient's leads were initially left and the patient was treated with iv antibiotics for 10 weeks.The patient was hospitalized due to worsening condition of the neck area, that had began to drain due to infection, and the lead was infected and extruding through the skin as well.The patient additionally had a red "pimple-sized" bump at their neck incision site where the lead was coming through.The patient then had their vns leads removed on (b)(6) 2018 due to the reported infection and foreign body response.The patient had discomfort at their neck due to the reported lead extrusion.The patient had their vns electrodes removed on (b)(6) 2019 due to the infection, foreign body response, and discomfort at neck caused by the presence of the electrodes.A review of the device history records verified that the implanted products were sterilized and passed all functional specifications prior to distribution.Device evaluation is not necessary as infection and wound dehiscence is not related to the functionality or delivery of therapy of the device.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 1000
• 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: 8506142
• MDR Text Key: 141666900
• Report Number: 1644487-2019-00699
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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
• Report Date: 04/11/2019

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: Lay User/Patient
• Device Expiration Date: 09/13/2019
• Device Model Number: 1000
• Device Lot Number: 204236
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/20/2019
• Initial Date FDA Received: 04/11/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/20/2017
• 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: 17 YR