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 08/19/2015

Event Type  malfunction  

Event Description

It was reported that the battery was replaced due to low battery ifi = yes condition.During product analysis, it was found that the battery had prematurely depleted contributing to the ifi = yes condition.Product analysis was performed on generator that was explanted and returned due to a low battery status(ifi-yes).A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The generator was interrogated and found to be at an ifi ¿ yes condition.A visual assessment on the pcba (printed circuit board assembly) showed contaminates on the trimmed edge of the pcba.The series resistor voltage 0.080mv, which translates to 8.0ua stand by current (supply current off-time (limits 1ua ¿ 5ua)), as measured at the product analysis bench, shows an increased current consumption (out of speciation) for the pulse generator.It was hypothesized that the trimmed edge of the pcba was disturbed during the open can process, removing the resistive paths that were established between the copper edges on the trimmed edge of the pcba.Therefore, the electrical performance of the generator, as measured in the pa bench, will be used to conclude that the contamination that was observed on the trimmed edge of the pcba suggested probable electrical paths (resistive path) were established between the copper edges on the trimmed edge of the pcba, which contributed to the ifi=yes condition.Other than the noted pcba debris, there were no performance or any other type of adverse conditions found with the pulse generator.A review of device history records for the generator shows that no unresolved non-conformances were found.The device met all specifications for release prior to distribution.The date of the trim test operation indicates the device was manufactured with the laser routing process that left certain devices susceptible to premature battery depletion.No additional relevant information has been received to date.

• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8764882
• MDR Text Key: 150159244
• Report Number: 1644487-2019-01268
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/05/2019

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: 08/11/2017
• Device Model Number: 106
• Device Lot Number: 203483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Event Location: Other
• Initial Date Manufacturer Received: 06/11/2019
• Initial Date FDA Received: 07/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2015
• 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: 49 YR