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

Model Number 106

Device Problems Nonstandard Device (1420); Failure to Sense (1559)

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

Event Date 10/30/2015

Event Type  malfunction  

Manufacturer Narrative

Suspect device udi: (b)(4).

Event Description

It was reported that the vns patient's device was unable to verify heartbeat detection during an office visit on (b)(6) 2015.Using heartbeat sensitivity level three, the device briefly displayed heartbeat for a few seconds but then showed bpm - ?????.The patient's device was tested and showed normal device function.The device was programmed to heartbeat sensitivity level two but the device continued to showed bpm - ?????.The tablet device was not plugged into the power outlet, the wand battery had been changed, and the device output currents were disabled.Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.Review of the available programming and diagnostic history confirmed normal diagnostic results during the office visit on (b)(6) 2015.(b)(4).Review of the decoder data indicated that the device was sensing heartbeat.No further relevant information regarding the event has been received to date.

Event Description

Review of the available programming and diagnostic history showed normal diagnostic results during the office visit on (b)(6) 2015.Review of the decoder data revealed that the device was sensing heartbeat.

Event Description

Heartbeat detection functionality was verified with alternate methods during an office visit on (b)(6) 2016 and successfully calibrated the device at heartbeat sensitivity level - 3.Diagnostics showed normal device function.

• 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: 5253786
• MDR Text Key: 32413061
• Report Number: 1644487-2015-06347
• 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
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2015

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: 07/29/2017
• Device Model Number: 106
• Device Lot Number: 203483
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/03/2015
• Initial Date FDA Received: 11/30/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/29/2015; 01/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z0280-2016
• Patient Sequence Number: 1
• Patient Age: 30 YR