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

Model Number 106

Device Problem Device Inoperable (1663)

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

Event Date 10/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported on (b)(6) 2016 that during a replacement surgery the old generator was removed and the new generator 106 was implanted and it was noted to be at end of service.(eos).It was stated that the generator was not at eos in the package and no cautery was used after the vns was introduced into the sterile field.When the new generator was initially interrogated it showed that output current was at 0 and the generator was fully charged.After the vns was plugged into the patient's lead system outside of the pocket it showed eos condition.This was noted after performing system diagnostics.A backup generator was used.The design history record for the generator showed that it passed all functional tests prior to distribution.No additional relevant information has been received to date.

Event Description

The generator was received for analysis on 11/15/2016.Product analysis is underway but has not been completed to date.

Event Description

Product analysis was completed on the generator.It was noted that the ¿pulsedisabled¿ byte was set to a value that represents a vbat

• 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: 6095886
• MDR Text Key: 60089371
• Report Number: 1644487-2016-02608
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/17/2018
• Device Model Number: 106
• Device Lot Number: 4909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 01/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2016
• 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: 42 YR