MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Seizures (2063)

Event Date 08/06/2018

Event Type  Injury  

Event Description

It was reported by the patient's father that the patient had 2 seizures which were more intense than usual, but the paralysis did not last as long as usual.The patient's father was concerned about the intensity and already informed the neurologist.The patient was seen by their neurologist and the settings were ramped up at that time.Additional information was reported that this patient was admitted to the hospital due to increased seizures.Multiple attempts for relevant information were made, but no information has been received to date.No other relevant information has been received to date.

Manufacturer Narrative

Adverse event or product problem, corrected data: initial report inadvertently listed malfunction instead of adverse event.Type of reportable event, corrected data: the initial report inadvertently listed malfunction instead of serious injury.

Event Description

The patient¿s father reported that the patient was doing better since the hospitalization.The doctor reported that the patient¿s increased intensity and increase in frequency of seizures was not related to the vns device.The believed cause of the increased intensity of the patient seizures and increased frequency was due to the patient¿s natural history of seizures.The increase in seizures was stated to be at or below pre-vns levels.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 1000
• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7806962
• MDR Text Key: 118001920
• Report Number: 1644487-2018-01466
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/28/2020
• Device Model Number: 1000
• Device Lot Number: 204508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 08/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2018
• 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; Required Intervention
• Patient Age: 5 YR