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

Model Number 106

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Tachycardia (2095)

Event Date 06/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported on (b)(6) 2016 that the patient had a prophylactic generator replacement that day.The patient was implanted with a m106 and systems diagnostics were normal with impedance of 2405 ohms with the new generator in the or.However, in the operating room (or) the patient's heartbeat was unable to be detected.All sensitivity settings were tried, but only ????s were observed.The surgeon had declined to do the ekg surface assessment.They did not replace the generator but just programmed it on to the same settings as the explanted 102.The design history records was reviewed and the generator passed all functional tests.R-wave verification passed prior to distribution as well.All testing (final r-wave twice, pcba level r-wave, and the sso sensing delay/leakage current tests) show that this device had the ability to sense within its specification in manufacturing.It was confirmed that the generator and lead electrodes were implanted very close to each other in a single incision fashion.The patient was seen for post-op appointment on (b)(6) 2016.Heartbeat detection was again tried but only ???? at settings 1-4 were seen.At setting 5 there were able to intermittently detect a heartrate at times (maybe 30-40% of the time).This heartrate was very erratic.It was over 200 bpm, around 89-91 bpm, and also around 45-50 bpm at different times.The patient's pulse was around 90.Since the hr detection was intermittent and inconsistent, the physician decided to leave the autostim current off (0.0ma).He did leave tachycardia detection on at a sensitivity of 5 with a 40% threshold.His thought was to capture the data on what the device was detecting.The patient's device is currently programmed with an off time of 0.5 min and this has been very effective for her.

Event Description

The patient had a follow-up appointment on (b)(6) 2016.A 2-position assessment was done for the generator site.R-waves while standing were barely discernible with < 0.2v amplitude.R-waves while the patient was laying on her left were 0.1-0.2v magnitude, still significantly less than 0.4v.Conclusion of the assessment was that inadequate r-wave amplitudes are present based on the implant location.The alternate placement measured at the axilla would be a good choice for a future replacement device if autostimulation mode is needed.

• 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: 5777706
• MDR Text Key: 49762933
• Report Number: 1644487-2016-01532
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/20/2017
• Device Model Number: 106
• Device Lot Number: 203494
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2016
• 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