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 Problems Seizures (2063); Anxiety (2328)

Event Date 02/20/2015

Event Type  Injury  

Event Description

It was reported that the patient has had an increase in seizures and was stressed about having their generator replaced.The patient had their generator replaced.The explanted generator was returned for product analysis.Product analysis was performed on the explanted generator.The battery voltage was 2.803 volts.The data in the diagaccumconsumed memory locations revealed that 97.351% of the battery had been consumed.A battery life calculation resulted in 4.9 years remaining before the near-end-of-service (neos) flag would be set.However, no programming/diagnostic history was available the as received parameters were used for the blc.Electrical test results showed that the pulse generator performed according to functional specifications.There were no adverse functional, mechanical, or visual issues identified with the returned generator.No other relevant information has been received to date.

Manufacturer Narrative

Corrected data, initial report: device manufacturing date was inadvertently not included.

• 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: 9628078
• MDR Text Key: 179419702
• Report Number: 1644487-2020-00113
• 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: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/07/2015
• Device Model Number: 103
• Device Lot Number: 202509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/02/2020
• Initial Date FDA Received: 01/24/2020
• Supplement Dates Manufacturer Received: 02/28/2020
• Supplement Dates FDA Received: 02/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2013
• 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: 38 YR