MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 104; GENERATOR

Model Number 104

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

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

Event Date 02/15/2018

Event Type  malfunction  

Event Description

It was reported that the patient¿s generator settings spontaneously changed to 0ma and the physician reports that the patient¿s battery was only 25% and the device was implanted less than one year ago.Data from the patient's device was received and reviewed.It was seen that the device was set to vbat < eos threshold when the device was interrogated on (b)(6) 2018.All outputs at this time were set to 0 ma including the magnet output.Lead impedance was within normal limits.The device was then programmed back on to desired settings.From reviewing the data, the generator is functioning properly and thus the only explanation for why the generator was at settings of 0ma upon interrogation is that the generator was likely in contact with some form of electrocautery on or around (b)(6) 2018.This may have been caused by event non-invasive procedure where possible electrocautery or radio frequency tools were used.As far as the generator¿s performance right now, all impedance values are within normal limits and the voltage of the battery (battery longevity) appears normal and was not significantly affected by this electrocautery use.No additional or relevant information has been received to date.

Event Description

Product analysis for the generator was completed and approved.The pulse generator was opened.A visual assessment on the pcba showed a reflective substance on the trimmed edge of the pcba (tab removed).In addition a white residue was observed surrounding all leads of the pcba processor.No other visual anomalies were identified.An intensified-follow-up-indicator warning message was verified in the analysis lab and found to be due to the pulse generator remaining ¿on¿ post explant.The device was opened and analyzed.During investigation, a white residue was observed surrounding the leads of the pcba processor.In addition, a reflective substance was observed on the trimmed edge of the pcba (tab removed), suggesting potential for an electrical path (resistive path), between the copper edges on the trimmed edge of the pcba.It is unclear if these findings may have been a contributing factor for the premature end of life indicator allegation.With the case removed and the battery still attached to the pcba, the series resistor measured 0.35mv, indicating no high current draw state and the battery measured 2.87 volts.

Event Description

A call was received from a company representative who stated he spoke with the physician and they theorized the pulse disablement may have been caused by a dental procedure.The generator was received into analysis.Analysis is underway but has not been completed to date.

Event Description

Clinic notes were received for patient referral for replacement.The patient¿s battery is now nearing end of service.The device was replaced.The explanted device has not been received for analysis to date.

• Brand Name: PULSE GEN MODEL 104
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, 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: 7570257
• MDR Text Key: 110177142
• Report Number: 1644487-2018-00944
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750047
• UDI-Public: 05425025750047
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/29/2018

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: 04/11/2019
• Device Model Number: 104
• Device Lot Number: 204134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/17/2018
• Initial Date FDA Received: 06/05/2018
• Supplement Dates Manufacturer Received: 08/22/2018; 09/13/2018; 10/17/2018
• Supplement Dates FDA Received: 09/10/2018; 10/04/2018; 10/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2017
• 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: 36 YR