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 Problem Unspecified Infection (1930)

Event Date 11/12/2018

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr? device evaluation is not necessary because the reported event have been determined as not related to vns therapy.

Event Description

It was reported that the patient presented with post-surgical fever, edema in the thoracic region and was treated with antibiotics without results.It was reported that the generator was explanted due to infection at the generator site.The hospital that performed the surgery has been closed due to an increase in hospital infection.Device history records were reviewed for the generator and lead.The devices passed all specification tests and were sterilized prior to distribution.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 additional or 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8233101
• MDR Text Key: 132597240
• Report Number: 1644487-2019-00008
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/09/2019

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: 04/17/2020
• Device Model Number: 106
• Device Lot Number: 204470
• Is the Reporter a Health Professional?: Yes
• Device Age: 5 MO
• Event Location: Other
• Initial Date Manufacturer Received: 12/18/2018
• Initial Date FDA Received: 01/10/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/07/2018
• 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: 10 YR