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

Model Number 106

Device Problems Premature End-of-Life Indicator (1480); Under-Sensing (1661)

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

Event Date 12/01/2016

Event Type  malfunction  

Event Description

Programming data for the patient's generator was reviewed and found that the generator was depleting prematurely.The generator was replaced due to battery depletion.The explanted generator was received and underwent analysis.The device¿s output signal was monitored for a 24 hour period and no variation was observed during this testing and the device provided the expected level of output current.The generator case was opened and debris was observed on the trimmed edge of the printed circuit board assembly.During testing the printed circuit board assembly failed several electrical and sensing tests, fine grit sandpaper was then used to remove contaminates from the printed circuit board assembly.The generator case was then reassembled and the generator met functional specification.Analysis was able to confirm that the debris on the printed circuit board assembly was the cause of the premature battery depletion and sensing issues.A previous internal investigation found that the laser routing process during manufacturing caused conductive debris to be left on the printed circuit board assembly.This debris resulted in leakage paths which were found to cause battery depletion and sensing issues.A review of manufacturing records found that the device was manufactured using the laser routing process.

• 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: 6839216
• MDR Text Key: 85612590
• Report Number: 1644487-2017-04408
• 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
• Report Date: 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/03/2017
• Device Model Number: 106
• Device Lot Number: 4410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2015
• 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: 53 YR