MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Failure to Sense (1559)

Patient Problem No Information (3190)

Event Date 04/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient's device heartbeat verification was unable to be performed by the neurologist during a follow up appointment.Programming history is available from date of implant, (b)(6) 2015 to (b)(6) 2016.One system diagnostic test was performed on (b)(6) 2015 and shows normal impedance of 2310 ohms.The battery indicator is ifi - no.On the date of implant, normal mode output current remained programmed off during the heartbeat testing but the magnet and auto-stimulation output current were turned on.Tachycardia detection was programmed on, and heartbeat detection at sensitivity level 1 was successful (60 beats per minute).On (b)(6) 2016, the heartbeat verification was attempted at sensitivity settings 5 and 4 and resulted in heart rate of 77.6 beats per minute.At the end of the visit, the device was programmed to heartbeat sensitivity setting 5, with td on and all output currents on with resulting heart rate as 67.8 beats per minute.A review of device history records for the generator shows that no unresolved non-conformances were found.

• 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: 5610396
• MDR Text Key: 44454732
• Report Number: 1644487-2016-00900
• 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: Physician
• Type of Report: Initial
• Report Date: 04/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/26/2017
• Device Model Number: 106
• Device Lot Number: 4605
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/01/2016
• Initial Date FDA Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2015
• 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 Age: 29 YR