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

Model Number 106

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 12/17/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was initially reported by the neurologist that he was unable to accurately detect the heart beat for the patient.It was noted he tried sensitivity settings 1 through 5, but only received.Troubleshooting was performed and it was found that the vns programming wand was working correctly, but that the data received light was not observed at all.The neurologist noted that upon initial interrogation of the patient's vns system, he was able to see the flickering of the data received light.The neurologist decided to program the autostim feature off, but left the normal mode and magnet mode programmed on.It was later noted by the company representative, who attended the vns implant surgery, that she was able to pick up the patient's heart beat right away, indicating the device was working properly.The company representative reached out to the neurologist to schedule an appointment where she would be able to help the neurologist with some troubleshooting.After the troubleshooting appointment, the company representative reported the issue of not being able to detect the patient's heart beat was repeated.The company representative tried changing rooms to eliminate possible sources of emi (electromagnetic interference).She verified all connections with the programming system were connected properly, turned off the lights, and checked the programming wand's battery life.The wand was also repositioned on the patient to try communicating from a different angle.Sensitivity settings 1 through 5 were all checked and it was verified that at the time of testing for the heart beat, the output current was programmed off.None of the troubleshooting resolved the issue.It was noted the device showed a heart beat once for a short period of time at setting 4, but went to all after.The programming history from the date of implant was reviewed and there were no anomalies noted which could have caused or contributed to the reported event.Attempts for additional relevant information have been unsuccessful to date.

Event Description

Review of the decoded data shows that on the date of the implant ((b)(6) 2016) for the m106 generator, sn: (b)(4), tachycardia detection was programmed off and sensitivity levels 1, 2, and 3 were tested.Interrogations were performed and showed 0 bpm, which would be expected with the tachycardia detection programmed off.System diagnostics were also performed, but the td was programmed off at the time.

• 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: 5427568
• MDR Text Key: 38646893
• Report Number: 1644487-2016-00278
• 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
• Report Date: 01/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/03/2017
• Device Model Number: 106
• Device Lot Number: 4407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2015
• 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: 22 YR