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

Model Number 106

Device Problems Under-Sensing (1661); Device Sensing Problem (2917)

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

Event Date 04/25/2016

Event Type  malfunction  

Manufacturer Narrative

Suspect device udi: (b)(4).

Event Description

It was reported that the patient's implanted generator was unable to verify heart rate measurements.This was attempted both within surgery and post-operative recovery.The patient's programmed current was reportedly enabled during the attempts to verify heart-rate.This was verified through the available programming history.All sensitivity values were attempted.There were no reported communication issues, and the diagnostic testing was within normal limits.The pre-surgical evaluation was not performed because the patient would not sit still long enough to get ecg readings.The surgeon reportedly placed the generator within the pocket as close to the heart as possible.The generator's device history record was reviewed, and all specifications were met prior to distribution.No additional pertinent information has been received to date.

Event Description

Downloaded internal device data was reviewed by the manufacturer.Sensitivity values used in lines of interrogated or diagnostic data were on lines 3 and 5.The foreground heart rate measured 60.0 bpm for each of these lines.The 60.0 bpm value in this instance represents a stale value that can indicate no valid r-r intervals were detected for an extended amount of time.Battery status was ok throughout the available data, and impedance values while the device was implanted were within normal limits.A follow up appointment with the patient's provider attempted heart rate detection with sensitivity values 4 and 5, both without success.The full troubleshooting procedure recommended by the manufacturer was not taken at that time.

Event Description

Troubleshooting was performed to test the heart rate verification on (b)(6) 2016.After interrogation and diagnostics, output currents were programmed to 0.The sensitivity value was noted to be 5.The heart rate verification registered a stable heart rate of approximately 72 bmp.The option to test another sensitivity value was taken to see if it is the best value.Sensitivity value 2 was then chosen.The heart rate readings fluctuated between 60 and 130 bmp and did not appear to be accurate.Sensitivity setting 3 was attempted with stable heart rate similar to setting 5.The sensitivity setting was left at 3.Current values were re-enabled to previous settings.Review of the internal device data from this appointment verified that the detected heart rate was within a physiological range and reached a registered value of 76.7 bpm with the sensitivity value of 3.

Event Description

It was reported that heart rate could not be detected on the patient¿s generator.The output currents were reportedly left on during this attempt to detect heart rate.No additional pertinent information has been received to date.

Event Description

Programming history and internal device data from the generator was reviewed.In the last available appointment, the data shows three lines of interrogation or diagnostic data where tachycardia detection was enabled.The foreground heart rate measured 97.9, 74.3, and 74.3 for those three lines.Sensitivity values used in these lines were setting 3 only, although 4 and 5 were present for programming actions.The internal data showed 90 tachycardia detections and 88 delivered autostimulations.Tachycardia detection and output currents were both on throughout the office visit.No anomalies were apparent from the data present.No additional pertinent information has been received to date.

• 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: 5670079
• MDR Text Key: 46781153
• Report Number: 1644487-2016-01068
• 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,Followup,Followup,Followup
• Report Date: 01/27/2017

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: Health Professional
• Device Expiration Date: 09/10/2017
• 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: 04/25/2016
• Initial Date FDA Received: 05/20/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 06/24/2016; 09/14/2016; 01/03/2017; 01/27/2017
• 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