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

Model Number 106

Device Problems No Device Output (1435); Device Operates Differently Than Expected (2913)

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

Event Date 06/02/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the physician had a patient who he could not get results from the heart rate detection feature.Some initial troubleshooting steps were performed, including attempting sensitivity settings 4 and 5, but this did not resolve the issue.The patient did not have pre-surgical evaluation done at the time of implant.The generator dhr was reviewed and found that all specifications were met prior to distribution.No additional pertinent information has been received to date.

Event Description

It was later reported on (b)(6) 2016 that the patient's vns system was recently interfaced with to troubleshoot the heart rate verification feature.This was after the previous reported attempt on (b)(6) 2016.The output currents were disabled on the generator.The heart rate verification was attempted and showed a stable heart rate value.No issues of difficulties were encountered while registering the heart rate.The generator's output currents were turned back on after the testing.No changes were made to the sensitivity setting throughout the testing.

• 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: 5752705
• MDR Text Key: 49031332
• Report Number: 1644487-2016-01434
• 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: 06/02/2016

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: 09/03/2017
• Device Model Number: 106
• Device Lot Number: 203513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/02/2016
• Initial Date FDA Received: 06/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 58 YR