MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problems Premature End-of-Life Indicator (1480); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem Seizures (2063)

Event Date 06/17/2015

Event Type  malfunction  

Event Description

The patient's physician informed that the generator battery status was ok in (b)(6) 2019, however the battery indicator in (b)(6) 2019 was now registering intensified follow up indicator (ifi-yes) status.It was mentioned that the patient was having increased seizures, which prompted the doctor to check the batter status and discover the ifi indicator.The patient is now being referred for generator replacement.The patient's mother was concerned that the generator battery depleted fast than expected.The device history record of the generator was reviewed, and it was confirmed that the device was laser-routed during the manufacturing process.Internal investigation showed that the observed premature battery life indicators were predominately caused by conductive debris from the laser-routing process resulting in leakage paths.Data from the patient's device was reviewed and it confirms that the battery depleted more quickly than expected.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Further follow up with the physician confirmed that the patient has not experienced an increase in seizures.The physician reviewed records from the patient's hospital visits, emergency room visits, admissions, changes in medication, and it was confirmed that the patient has been very stable.Additionally, it was reported that the patient's generator has been explanted and replaced.The explanted generator has been received by the manufacturer for product analysis.Analysis is underway but has not been completed to date.

Event Description

Product analysis was completed on the explanted generator.In the product 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 pulse generator performed according to functional specifications.A visual assessment on the pcba showed contaminates on the trimmed edge of the pcba.The battery was removed.Fine grit sandpaper was used for the removal of the observed contaminates from the trimmed edge of the pcba.After the trimmed edge of the pcba was cleaned, a postburn electrical test showed that the pcba performed according to functional specifications.Based on these findings, the contamination that was observed on the trimmed edge of the pcba suggest probable electrical paths (resistive path) were established between the copper edges on the trimmed edge of the pcba, which contributed to the supply current conditions.There were no performance or any other type of adverse conditions found with the pulse generator.

• Brand Name: PULSE GEN MODEL 105
• 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: 8786040
• MDR Text Key: 150872694
• Report Number: 1644487-2019-01362
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750054
• UDI-Public: 05425025750054
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2017
• Device Model Number: 105
• Device Lot Number: 203396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 09/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2015
• 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: 8 YR