MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem High impedance (1291)

Patient Problem Seizures (2063)

Event Date 03/01/2017

Event Type  malfunction  

Manufacturer Narrative

Event Description

It was reported that a patient had high impedance.The patient was having an increase in seizures.The patient's x-rays were examined, which indicated that the pin was not fully inserted into the generator.The patient's physician believes the increase in seizures is due to the high impedance.Surgery is likely but has not occurred to date.No additional or relevant information has been received.

Event Description

Generator analysis was completed and approved.The generator output signal was monitored for more than 24 hours, placed in a simulated body temperature environment and showed no signs of variation in the output signal.The device showed it was able to provide the expected level of output current for the entire monitoring period.The generator diagnostics were expected for the programmed settings.The connector block and header lead pin cavity passed all functional testing, the generator had expected diagnostic test results for convertor codes at various load resistances, and the septum cavity passed dimensional evaluation.Photo of returned set screw revealed indentions on the bottom of the screw indicating tightening to the lead pin or test resistor.The device performed according to functional specifications of the current automated final test and analysis in the lab concluded proper functionality of the pulse generator and that no abnormal performance of any other type of adverse condition was found.

Event Description

The patient¿s generator was explanted due to high impedance and worsening seizures.X-rays showed pin was dislodged from header and patient had generator replaced.The surgeon did not reinsert the pin into the model 102 because we had already planned to upgrade to the model 106.Generator was received for analysis.Analysis is underway but has not been completed to date.No additional or relevant information has been received to date.

Event Description

Current programming history was received and reviewed for the patient.No additional or relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• 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: 8130760
• MDR Text Key: 129315608
• Report Number: 1644487-2018-02193
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750016
• UDI-Public: 05425025750016
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/09/2017
• Device Model Number: 102
• Device Lot Number: 4295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/30/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2015
• 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): Required Intervention
• Patient Age: 29 YR