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 01/30/2017

Event Type  Injury  

Event Description

It was reported that a patient's device was replaced for an unknown reason.From follow-up on the reason, it was indicated that the replacement was due to " intensified follow-up indicator" and increased seizures.Review of the manufacturer's programming history database noted that the last diagnostics from the patient's device was recorded from the week before explant indicating that status checks were within normal limits.The explanted device was to be returned, however no device has been received to date.No additional relevant information has been received to date.

Event Description

Follow up with the physician noted a "significant decline in seizure control" first recorded on (b)(6) 2017 that was attributed to low battery.A diagnostic performed at the next office visit indicated that the device was functioning as intended within normal limits.It was stated that the patient requested urgent replacement.No device was returned to date.No additional relevant information was received to date.

Event Description

The device was returned for analysis.Product analysis was completed.The generator would not interrogate upon receipt.The battery voltage confirmed an end of service (eos) condition.No apparent anomalies were identified and it was determined that the end of service condition was an expected event.No additional performance or any other type of adverse conditions were found with the generator.No additional relevant information was received to date.

• 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: 8142864
• MDR Text Key: 129637299
• Report Number: 1644487-2018-02242
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/09/2014
• Device Model Number: 103
• Device Lot Number: 2002007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 01/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2012
• 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: 20 YR