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 Arrhythmia (1721)

Event Date 05/31/2018

Event Type  Injury  

Event Description

It was reported that during the lead replacement surgery for high impedance, which is reported in mfg. Report #1644487-2018-01042, an erratic heart rate was observed when the vns was programmed to the pre-op settings. The in-pocket vns diagnostics were within normal limits and heartbeat detection was verified within 1 beat per minute, or bpm, at 70 bpm. It was stated that there was slowing and increasing of the heart rate. The surgeon stated that this was likely the result of stimulation on a "fresh" portion of the nerve. It was decided to disable the vns and allow the patient's physician to titrate the device. 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7626459
• MDR Text Key: 111924414
• Report Number: 1644487-2018-01047
• Device Sequence Number: 1
• Product Code: LYJ
• 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

• Type of Report: Initial
• Report Date: 06/21/2018

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 06/21/2018
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: LAY USER/PATIENT
• Device EXPIRATION Date: 02/16/2020
• Device MODEL Number: 106
• Device LOT Number: 202553
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: Other
• Date Manufacturer Received: 05/31/2018
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 03/02/2018
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 06/21/2018 Patient Sequence Number: 1