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

Model Number 106

Device Problems Device Operates Differently Than Expected (2913); Programming Issue (3014)

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

Event Date 07/29/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during an initial implant surgery an m106 was unable to sense the patient's heart rate after trying each sensitivity setting.Pre-surgical ekg testing was not performed.Sensing was able to be achieved at level 1 but only for 10 seconds after which the unable to sense error message appeared intermittently.Follow-up to the company representative who was at the surgery revealed the generator was tried in various positions and could not detect.The programming computer was not plugged in, tachycardia detection was set to on.He stated that the programming wand was not turning off during the detection.It was verified that the detection level was being changed at each change of settings the generator was not being manipulated at the time of each sensing attempt.The device history record was reviewed for the suspect device, and the generator passed all functional specification and electrical tests.Attempts for additional relevant information have been unsuccessful to date.

Event Description

Review of available programming history revealed a systems diagnostics which was within normal limits.All output currents remained programmed off during the time of the undersensing event.Follow-up to the physician after the patient's first dosing appointment revealed the unit was activated with no ill effect to the patient.Heart-rate detection was not noted at the visit.Diagnostics from the appointment were not available.No additional information has been received to-date.

Manufacturer Narrative

Evaluation codes, corrected data: the previously submitted manufacturer report inadvertently reported the results and conclusions codes incorrectly.Remedial action initiated; corrected data: the previously submitted manufacturer report inadvertently did not include the actions taken for the reported event.Action reported to fda; corrected data: the previously submitted manufacturer report inadvertently did not include the internal reporting number assigned for the actions for the reported event.

Event Description

A company representative attended the patient's appointment and performed heartbeat testing for the patient's device.The patient's heart rate was verified to be detected by the generator.The pre-operative assessment was performed without issue.All 7 ecg positions were performed without issue.Readings were found and it was determined the patient should be at a sensitivity of 1.It was reported the patient would continue to be titrated.Programming history review was performed 01/18/2016.Review of the patient's in-house programming history revealed data from (b)(6) 2015.Data was available from the clinic visits on 08/(b)(6) 2015, where the patient was titrated to higher settings.Autostimulation was programmed on (b)(6) 2015.

• 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: 5036836
• MDR Text Key: 25144326
• Report Number: 1644487-2015-05619
• 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: Followup,Followup
• Report Date: 07/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2017
• Device Model Number: 106
• Device Lot Number: 4410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2015-002-C
• Patient Sequence Number: 1
• Patient Age: 35 YR