MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problem Protective Measures Problem (3015)

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

Event Date 01/14/2014

Event Type  malfunction  

Event Description

It was reported that the patient underwent vns generator replacement due to battery depletion and the desire for a new vns generator model.The explanted product was received by the manufacturer.Generator product analysis was completed.The generator diagnostics were as expected for the programmed parameters.The battery measured 2.916 v at the completion of the fet.The generator performed according to functional specifications with the exception of the output pulse risetime test, which failed multiple times.The generator case was removed and cracks and discoloration were observed on the feed-thru capacitor, as well as separation of the silver polymide on the feed-thru capacitor wires.Testing with a known good printed circuit board assembly attached to the case with the suspected feed-thru capacitor confirmed that the capacitor was the source of the output pulse risetime failure.Other than the noted event, there were no additional performance or other adverse conditions found with the generator.A review of device history records revealed that the generator was sterilized and passed quality control inspection prior to distribution.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 105
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8100113
• MDR Text Key: 128253618
• Report Number: 1644487-2018-02139
• 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
• Report Date: 11/23/2018

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: 12/05/2015
• Device Model Number: 105
• Device Lot Number: 3840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Event Location: Other
• Initial Date Manufacturer Received: 11/06/2018
• Initial Date FDA Received: 11/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2014
• 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: 12 YR