MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

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

Patient Problem Seizures (2063)

Event Date 04/12/2019

Event Type  Injury  

Event Description

It was reported that the patient was hospitalized and referred for vns battery replacement on (b)(6) 2019.The patient underwent replacement due to battery depletion.The operating room representative who attended the surgery indicated that when he arrived at the case, the patient was already prepped on the table followed by a quick battery change.The surgeon and team were hurried with another case to follow and did not get a chance to obtain pre-op diagnostics and clarification for battery change.The generator has been received for analysis which has not been completed to date.Information was received from a nurse at the neurosurgery department.It was stated that the patient was hospitalized due "mental status changes" after falling in the shower.She stated the patient's vns was interrogated during normal work up and found to have low battery.She stated they thought the patient may have had a seizure, but are not sure the patient had a seizure, why the patient fell in the shower, or the cause of the potential "seizure".She stated the patient was also found to have pneumonia, unrelated to the vns, which also could have caused the "seizure".The nurse was unsure if the low battery was alleged to be the cause of the seizure.No additional information has been received to date.

Event Description

Product analysis for the generator was completed and approved.Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was successfully verified in the lab.The device output signal was monitored for more than 24 hours, 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 pulse generator performed according to functional specifications.There were no performance or any other type of adverse conditions found with the pulse generator.

• Brand Name: PULSE GEN MODEL 103
• 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: 8588240
• MDR Text Key: 144326695
• Report Number: 1644487-2019-00878
• 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,Followup
• Report Date: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/15/2011
• Device Model Number: 103
• Device Lot Number: 201079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2009
• 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): Hospitalization; Required Intervention
• Patient Age: 82 YR