MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problems No Display/Image (1183); Premature End-of-Life Indicator (1480)

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

Event Date 08/15/2017

Event Type  malfunction  

Event Description

Report received that after system diagnostics were performed, the battery status of a generator had unexpectedly changed.System diagnostic tests returned normal results.A review of the device history record indicated the generator had passed all quality inspections and electrical tests prior to release for distribution.No further information has been received to date.

Event Description

Further information was received by analyzing the programming data for the generator.The data observed from the visit about two months prior to the event showed an expected measured battery voltage compared to the estimated charge consumed.This was displayed as a battery indicator of 100%.The data observed on the day of the event showed that upon interrogation, the measured battery voltage was indicative of 25% battery remaining and the 25% battery indicator was displayed.The estimated charge consumed indicated about 90% of the battery should have remained.After a system diagnostic test was performed, the measured battery voltage rebounded to a higher voltage and the battery indicator was 100%, consistent with the expected charge consumed.A second system diagnostic test was run and similar results were seen.No further relevant information has been received to date.

Event Description

More programming data was received and analyzed.The new data was obtained from a programming session about two months after the event was first seen.Upon interrogation, the measured battery voltage was seen to be greater than the previous session indicating it continued to rebound.The voltage was expected based on the estimated charge consumed at this time, and a battery indicator of 100% was displayed.At the end of this programming session, the generator was interrogated again and the measured battery voltage was even greater than it was at the start of the session.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• 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: 6852349
• MDR Text Key: 85385879
• Report Number: 1644487-2017-04423
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2017

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: 02/11/2019
• Device Model Number: 106
• Device Lot Number: 204045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/15/2017
• Initial Date FDA Received: 09/08/2017
• Supplement Dates Manufacturer Received: 09/22/2017; 10/24/2017
• Supplement Dates FDA Received: 10/19/2017; 11/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2017
• 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