MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Under-Sensing (1661)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2016

Event Type  malfunction  

Event Description

It was reported that heart rate could not be detected on the patient¿s generator.The output currents were reportedly left on during this attempt to detect heart rate.The generator device history record was reviewed and showed all specifications were met prior to distribution.The trim test tab operation record showed that the generator is a mechanically routed device.No additional pertinent information has been received to date.

Event Description

Programming history and internal device data from the generator was reviewed.In the last available appointment, the data shows three lines of interrogation or diagnostic data where tachycardia detection was enabled.The foreground heart rate measured 80.3 for those three lines.The sensitivity value used in these lines was setting 5.The internal data showed 89 tachycardia detections and 76 delivered autostimulations.Tachycardia detection and output currents were both on throughout the office visit.No anomalies were apparent from the data present.No additional pertinent information has been received to date.

Event Description

It was reported that the heart rate detection feature on the patient¿s generator was functioning as intended.No additional pertinent information has been received to date.

Event Description

The patient's generator was prophylactically replaced and the device was returned to the manufacturer for analysis.The generator has been received, but analysis has not been completed to date.

Manufacturer Narrative

(b)(4).

Event Description

Analysis on the generator was approved.The device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.There were no performance or any other type of adverse condition found with the pulse generator.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6219564
• MDR Text Key: 63761267
• Report Number: 1644487-2017-02966
• 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,Followup,Followup,Followup,Followup
• Report Date: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/10/2017
• Device Model Number: 106
• Device Lot Number: 203513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2015
• 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: 43 YR