MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 12/15/2015

Event Type  malfunction  

Event Description

It was reported that a vns patient underwent lead replacement surgery on (b)(6) 2015.During the connection of the new lead to the existing generator, when the hex wrench was removed after tightening the setscrew, the septum plug pulled out, and remained on the shaft of the hex wrench.The surgeon tried to put the plug back in place into the generator's header.As there is no way to guarantee that the septum plug will remain in place after it has come out, it was decided to replace the generator too.No patient adverse events were reported.The lead was replaced due to high impedance.This event was reported in the medwatch report number 1644487-2015-06742.Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.The return of the explanted generator is expected but it has not been received to date.

Event Description

The explanted generator was returned to the manufacturer on (b)(6) 2016.Analysis is underway but it has not been completed to date.

Event Description

Analysis of the returned generator and septum was completed.Product analysis (pa) indicates that the reported allegation of ¿detachment of component(s)/septum plug¿ cannot be evaluated in the pa laboratory setting.However, measurements obtained in the pa lab of the original generator header septum cavity and septum dimensions meet specification.Septum was returned after the pulse generator had already been received and an analysis completed on it.The septum and setscrew were placed in the header septum cavity of the original generator and the setscrew was successfully secured by a bench torque wrench.In addition, the septum sealed properly in the header septum cavity.The septum was measured and meets specification for the septum measurements.Observed condition of the septum suggests manipulation during the attempted implant procedure contributed to the detachment event.Other than the damage to the septum, there were no other anomalies found.In the pa lab, the device output signal was monitored for more than 24-hrs, 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.The generator performed according to functional.There were no performance or any other type of adverse conditions found with the pulse generator.

• Brand Name: PULSE GEN MODEL 102
• 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: 5346606
• MDR Text Key: 35609806
• Report Number: 1644487-2016-00042
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2015

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: 09/30/2015
• Device Model Number: 102
• Device Lot Number: 3805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/15/2015
• Initial Date FDA Received: 01/06/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/04/2016; 02/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2013
• 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: 15 YR