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 Problem Dyspnea (1816)

Event Date 12/21/2018

Event Type  Injury  

Event Description

It was reported that the patient was not able to breath following the initial vns implantation surgery.It was stated that the patient¿s vns was programmed on following the implant, which was against the manufacturer's labeling, and that, an hour later, the patient could not breathe.The facility used magnet disablement until the company representative could arrive to disable the vns.It was stated that the physician did not believe the breathing issues were related to the vns, but the pre-existing conditions and the vns surgery.Follow up with the company representative revealed that the breathing issue resolved prior to device disablement, whether by programming or magnet disablement.The medical professional stated that the intervention was both for the patient's comfort and to preclude serious injury.Diagnostics were within normal limits.No additional 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: 8243000
• MDR Text Key: 132906451
• Report Number: 1644487-2019-00064
• 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: 01/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/17/2020
• Device Model Number: 1000
• Device Lot Number: 204502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2018
• 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: 3 YR