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 Seizures (2063)

Event Date 01/18/2019

Event Type  Injury  

Event Description

It was reported that the patient has had an increase in seizures since the new device has been turned on.The patient presented seizures at the time of turn on and she does not tolerate the minimum parameters nor the system diagnostic.He decided to turn off and wait longer in case the nerve was affected at the time of manipulation during the lead placement.It was not possible to perform a post-operative system diagnostic because when they began the diagnostic the seizure came and the doctor orders to pull off the wand.Review of the device history record for the generator was completed.The device passed all specifications prior to distribution.The device history record was also reviewed for the implanted lead and the lead also passed all specifications.They have not tried to perform system diagnostics again since last time after surgery.The seizures increased only at the time of turn on the stimulator if vns is shut down the seizures are the same before the surgery.No additional or relevant information has been received to date.

Event Description

Additional information was received that during the patient¿s follow-up appointment, the physician talked with the mother of the patient before checking her and told her that they will say to the patient that the device is turned on but in reality will be off.When they interrogated the device, the patient had a ¿seizure¿ and then the doctor saw in the parameters that the device was still off.The patient was hospitalized and they told her that will put her on ¿valium¿ and the seizure ended immediately.The conclusion from the physician was that the patient is making pseudo crisis (seizure), and the doctor will refer her to the psychiatrist and he will make a video eeg.The generator will continue in off mode.

Manufacturer Narrative

Relevant date; corrected data; initial mdr inadvertently omitted information known at time of submission.

Event Description

The device is currently still off.The physician is waiting more time to try the system diagnostic.No additional relevant information has been received to 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: 8520377
• MDR Text Key: 142133664
• Report Number: 1644487-2019-00718
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/08/2020
• Device Model Number: 106
• Device Lot Number: 005870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2018
• 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
• Patient Age: 28 YR
• Patient Weight: 72