MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 304

Model Number 304-20

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

Patient Problem Tissue Breakdown (2681)

Event Date 11/19/2020

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary because the reported event has been determined as not related to vns therapy.

Event Description

It was reported that the patient presented with inflammation of the wound at the neck site, and the wound was opened with appearance of inflammatory fluid and exposure of the lead.The wound was cleaned and samples were taken, no bacteria was found in the culture.The wound was then opened a second time and the lead was exposed again.The lead was then explanted.It was noted that per the physician, the cause of the lead extrusion was due to foreign body response.The patient had developed covid-19 post-implantation of vns.Device history records were reviewed for the lead.The lead passed all specifications prior to distribution and was hp sterilized.Device return and evaluation is not necessary because 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: LEAD MODEL 304
• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 11012585
• MDR Text Key: 221562268
• Report Number: 1644487-2020-01682
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• Combination Product (y/n): N
• Reporter Country Code: EC
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2020

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: 03/11/2023
• Device Model Number: 304-20
• Device Lot Number: 6163
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/15/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/20/2019
• 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): Other; Required Intervention
• Patient Age: 13 YR