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 12/01/2018

Event Type  malfunction  

Event Description

It was reported that the physician felt that the patient's vns had prematurely depleted as it was a laser routed device.It was explained that not all laser routed device exhibit premature depletion, but the physician was adamant that the device had prematurely depleted.A review of device history records revealed that the generator passed quality control inspection prior to distribution.The device was found to have been manufactured using the laser routing process.Based on available data, premature battery depletion was not verified.The percent battery capacity used and percent battery capacity remaining appears to match the expected values.No additional relevant information has been received to date.

Event Description

The physician's more recent tablet data for the generator was received and reviewed by the manufacturer.As the generator was implanted approximately four years ago and the 25% indicator has not yet been flagged, there was no indication that the device battery was depleting prematurely.

Event Description

It was later reported that the patient's physician felt that the patient was not receiving therapy from the affected device.Although the device lifetime may be reduced, its functions are not affected by this issue and the delivery of therapy is unaffected until the device reaches end of service (eos).No additional relevant information has been received to date.

Event Description

The premature end of life, or peol, allegation was assessed using a formula created to better characterize measurements of normal versus premature depletion for the m105 and m106 laser-routed versus non-laser routed populations.The calculation confirmed that there was no indication that the device was depleting prematurely.It was reported that the patient underwent prophylactic vns generator replacement surgery.During attempts at product return, it was revealed that the facility, historically, does not return explanted product per their risk management.

• 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: 8186309
• MDR Text Key: 131154697
• Report Number: 1644487-2018-02365
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/10/2019

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: 04/16/2017
• Device Model Number: 106
• Device Lot Number: 4349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/01/2018
• Initial Date FDA Received: 12/20/2018
• Supplement Dates Manufacturer Received: 02/13/2019; 03/22/2019; 09/18/2019
• Supplement Dates FDA Received: 03/07/2019; 04/15/2019; 10/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2015
• 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: 7 YR