MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Device Inoperable (1663)

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

Event Date 04/13/2015

Event Type  malfunction  

Event Description

It was reported that during initial implant surgery on (b)(6) 2015, the vns patient¿s device was tested after the lead pin was tunneled from the neck incision site to the generator pocket and system diagnostic results showed an end of service condition.The device was tested prior to tunneling the lead which showed battery status as ok.Another generator was used for the implant and the procedure was completed.Review of the internal device data shows that battery voltage was measured at 3.243v and pulse enabled during a system diagnostics test performed on (b)(6) 2015 at 01:11:34 pm.Another system diagnostic test was subsequently performed at 01:29:13 pm which measured the battery voltage at 1.941v and pulse disabled due to vbat < eos threshold.The explanted generator has been returned to the manufacturer where analysis is currently underway.

Manufacturer Narrative

(b)(4).Review of the available programming and diagnostic history.

Event Description

Analysis of the returned generator was performed and burn marks were observed on the pulse generator case, indicating that the pulse generator may have been exposed to an electro-cautery tool during device implant, which may have been a contributing factor.A reset of the pulsedisable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing.The battery of the returned generator was measured as 3.048 volts showing an ifi=no condition.The downloaded data revealed that 0.938% of the battery had been consumed.Other than the observed pulse disablement and burn marks, there were no performance or any other type of adverse conditions found with the pulse generator.The cause for the reported premature battery depletion was due to electromagnetic induction (emi) or electrostatic discharge (esd) transients.Premature battery depletion can result from the use of electrocautery during surgery or an electrostatic discharge imparted to the generator through the torque wrench used.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4757606
• MDR Text Key: 5952147
• Report Number: 1644487-2015-04649
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Model Number: 103
• Device Lot Number: 203216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2015
• 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: 20 YR