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); Paralysis (1997); No Code Available (3191)

Event Date 05/13/2019

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary as the reported event of infection is not related to the functionality or delivery of therapy of the device.(b)(4).

Event Description

It was reported by the patient¿s mother that the patient was initially implanted with vns and then had it explanted a week later.She asked whether the device was supposed to programmed off prior to having it explanted and was informed there was no information available to indicate this had to be done.It was discussed whether the lead should be left in and was informed of fibrosis being a possibly occurring.How much of the lead should be left in was also discussed.It was stated the patient had a (b)(6) infection which worsened since it was not seen by the doctor after missing two appointments.Once the patient was seen by the physician, he was admitted to the hospital and could not move his legs.The patient was released with high sodium levels.The mother indicated the patient was in critical condition and was having kidney failure and other unspecified adverse events.The mother of the patient was asked whether the patient was not having any of these events prior to having surgery and stated he was not.Per the mother, the patient could previously talk and such indicating he was no longer doing this and was having a speech impediment.It was not specified whether this was after the implant or explant surgery.The device history record's of the lead and generator were reviewed.The generator and lead passed final quality and functional specifications prior to release.Sterilization of the products was verified prior to release.No additional 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: 8679069
• MDR Text Key: 147336765
• Report Number: 1644487-2019-01078
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/07/2019

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: 02/23/2020
• Device Model Number: 106
• Device Lot Number: 5664
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/13/2019
• Initial Date FDA Received: 06/07/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/15/2018
• 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): Other; Required Intervention
• Patient Age: 43 YR