MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Output Problem (3005)

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

Event Date 06/23/2011

Event Type  malfunction  

Event Description

The vns generator was explanted and replaced due to battery depletion, and the explanted product was received back to the manufacturer for product analysis.During visual analysis, a bubble was observed in the generator header that placed the device component outside of its listed product specification.The bubble was found between two feedthru wires and bridged two non-common conductors.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications; however, an atypical output waveform was observed during testing.While performing system diagnostic tests, the pulse generator is connected to an oscilloscope to observe the output waveform.An atypical output waveform was observed in the product analysis lab, and it was concluded that moisture was causing leakage to increase in header.The phenomenon, however, had no adverse effect on either the diagnostic tests or the comprehensive automated electrical test results; all results were successful.The device history record was reviewed, and the generator successfully passed all assembly steps, including header securement and backfill.This is the process step during which the feed through cavities are completely backfilled with silicon.However, given the failure mode observed, it appears this process step was not completed adequately.Besides this event, there were no performance or any other type of adverse conditions found with the pulse generator.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 9240778
• MDR Text Key: 163919455
• Report Number: 1644487-2019-02080
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2019

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: 12/28/2012
• Device Model Number: 103
• Device Lot Number: 2916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Event Location: Other
• Initial Date Manufacturer Received: 10/02/2019
• Initial Date FDA Received: 10/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2011
• 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: 27 YR