MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

Model Number 302-20

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

Patient Problems Pocket Erosion (2013); Post Operative Wound Infection (2446)

Event Date 04/07/2016

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr?, device evaluation is not necessary as infection is not related to the functionality or delivery of therapy of the device.

Event Description

It was reported by an mri technician that a patient' vns was explanted due to an infection and a lead anchor eroding through the skin.Operative notes were received which indicated that the lead anchors were eroding through the skin, so to prevent infection and skin breakdown, the patient's lead and generator were removed.Patient was provided antibiotics.No cause of lead anchors eroding was noted in the notes.The manufacturer's device history records for the generator and lead were reviewed.Sterility of both products prior to release was verified.Device evaluation is not necessary as infection is not related to the functionality or delivery of therapy of the device.No further relevant information ha been received to date.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 12345891
• MDR Text Key: 267431583
• Report Number: 1644487-2021-01162
• Device Sequence Number: 1
• Product Code: MUZ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 08/19/2021

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: 02/28/2009
• Device Model Number: 302-20
• Device Lot Number: 200111
• Event Location: Other
• Initial Date Manufacturer Received: 08/11/2021
• Initial Date FDA Received: 08/19/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/15/2006
• 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: 48 YR