MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 09/10/2019

Event Type  Injury  

Event Description

It was reported that the patient was being referred for replacement due to the generator behaving erratically (stimulating when the patient is not having seizures) and battery status at 25-50%.No additional information has been received to date.No known surgical intervention has occurred to date.

Event Description

The generator was received for analysis.Analysis is currently underway and ha snot been completed and approved to date.

Event Description

Product analysis for the generator was completed and approved.Both interrogation and system diagnostic test were performed, with a distance of one and one-quarter inches (spacer block) between the pulse generator and the programming wand.Resulting status checks for; communication were ok, lead impedance and current delivered were normal for all diagnostic tests performed.In the analysis lab, the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the device performed according to functional specifications.The battery, 3.00 volts (ifi range 2.41v - 2.74v) as measured during completion of test parameter 7.16.10.2 (measured diagvbat) of the final electrical test, shows an ifi=no condition.The data in the diagaccumconsumed memory locations revealed that 63.203% of the battery had been consumed.A visual assessment on the circuit board assembly showed no visual anomalies.There were no performance, or any other type of adverse conditions found with the pulse generator.

Event Description

Generator replaced prophylactically.The explanted generator has not been received for analysis to date.

Manufacturer Narrative

Corrected data, initial report: last known system diagnostics inadvertently listed wrong date.

• Brand Name: PULSE GEN MODEL 106
• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 9158496
• MDR Text Key: 161420477
• Report Number: 1644487-2019-01924
• 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,Followup
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/10/2017
• Device Model Number: 106
• Device Lot Number: 203513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/11/2019
• Initial Date FDA Received: 10/04/2019
• Supplement Dates Manufacturer Received: 11/07/2019; 11/12/2019; 12/18/2019; 01/15/2020
• Supplement Dates FDA Received: 11/07/2019; 12/04/2019; 01/10/2020; 02/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2015
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 21 YR