MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Premature End-of-Life Indicator (1480)

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

Event Date 09/26/2018

Event Type  malfunction  

Event Description

It was reported that the patient was referred for vns generator replacement surgery.The patient underwent replacement surgery and the implant card received by the manufacturer indicated that the reason was due to battery depletion.The explanted generator was received by the manufacturer.Generator product analysis was completed.The end of service, or eos, allegation was not duplicated in the product analysis, or pa, lab.The battery measured 2.976 v at the completion of the fet, indicating an intensified follow-up indicator, or ifi, = no condition.The device performed according to functional specifications.A visual assessment of the printed circuit board assembly, or pcba, revealed contaminates on the trimmed edge of the pcba.The data dump was reviewed and at the time of review, the battery voltage measured 2.710 (ifi = yes).The diagaccumconsumed value was 74.817%.High impedance was observed on the day after the implantation of the generator.No further high impedance were observed in the lead impedance history until after generator explantation.The high impedance was reported in mfg.Report #1644487-2019-00019.The data in the ¿diagvbat_min¿ memory locations show a value of 2.674 volts approximately a week and a half post-explant.There were no performance or other adverse conditions found with the generator.Based on the data available through product analysis, it was unclear whether a premature end of life indicator was present at the time of the explant.A review of device history records revealed that the generator passed quality control inspection prior to distribution.No additional relevant information has been received to date.

Event Description

Review of the diagnostics from the date of explant revealed that the diagnostics were within normal limits with an intensified follow-up indicator, or ifi, = no battery status indicator.The observed diagvbat_min value was the result of the post-explant battery depletion.This was not indicative of a device failure.

• Brand Name: PULSE GEN MODEL 106
• 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: 8223607
• MDR Text Key: 132278731
• Report Number: 1644487-2019-00021
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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,Followup
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/08/2017
• Device Model Number: 106
• Device Lot Number: 4363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 01/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2015
• 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: 56 YR