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

Model Number 103

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 10/09/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014 it was reported that the device was explanted on (b)(6) 2014 due to a malfunction.No further information was received.The explanted generator and lead were returned for product analysis on (b)(4) 2014.Product analysis is still underway and has not yet been completed.

Event Description

Analysis of the generator and lead were completed.The reported malfunction allegation not duplicated in the laboratory.The device output signal was monitored for more than 24-hours, while the generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery shows an ifi=no condition.The septum was cored, but not in the slit of the septum.Bodily fluid remnants were observed in the header septum cavity, on/in the negative connector block, and on the setscrew.However, no pitting or corrosion was observed.In addition, the setscrew socket shows mechanical wear (more than typically observed), indicating multiple insertions and/or insertion attempts into the setscrew socket, which may have been a contributing factor for the cored septum.Therefore, this observation/finding is not considered a device failure, but instead the result of extensive manipulation of the product.Other than the septum anomaly (visual analysis), there were no performance or any other type of adverse conditions found with the pulse generator.Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product.The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted.Based on the findings in the lab, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints.It was reported in 2013 that the patient went to the surgeon initially and decided to move forward with repositioning her generator due to patient comfort which the surgeon agreed.However, the patient was later unwilling and wanted the device explanted.The patient had previously expressed desire to have vns explanted as also previously reported in manufacturer report #: 1644487-2013-03087.

• 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: 4245161
• MDR Text Key: 5050934
• Report Number: 1644487-2014-02996
• 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: Other,Consumer,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/17/2014

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: 06/30/2014
• Device Model Number: 103
• Device Lot Number: 3382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/12/2014
• Initial Date FDA Received: 11/12/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2012
• 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: 53 YR