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

Model Number 106

Device Problem Device Sensing Problem (2917)

Patient Problem No Information (3190)

Event Date 01/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported on (b)(6) 2016 that during a replacement surgery the m106 device was unable to detect heart rate.It was stated that diagnostics were able to be taken and were within normal limits.The tc saw a combination of "????" as well as "****" when attempting to establish the hr for the generator.For a moment a heart rate of 113 bpm was sensed but then went away.Sensitivity settings 1-5 were tried multiple times.No pre-surgical evaluation was done on the patient.The tc noted that the data received light appeared to be blinking during the test and the green power stayed on during the duration of the test.It was noted by the surgeon that the patient appeared very small and the generator was placed "superficially." the wand was not touching the generator during the running of the test.Since troubleshooting was exhausted a new generator was used, and the heart rate was picked up on a sensitivity of '1' immediately at a heart rate of 78.The explanted m106 device has not been received to date.

Event Description

The explanted generator was received for analysis on 02/12/2016.Product analysis is underway but has not been completed 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: 5434101
• MDR Text Key: 38776400
• Report Number: 1644487-2016-00294
• 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: 01/20/2016

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: 07/30/2017
• Device Model Number: 106
• Device Lot Number: 203469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/20/2016
• Initial Date FDA Received: 02/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/11/2015
• 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: 14 YR