MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 105

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

Patient Problem Seizures (2063)

Event Date 02/18/2019

Event Type  malfunction  

Event Description

It was reported that a patient used his magnet and he dropped to his knees and then went into a grand mal seizure.He has not used his magnet since his implant last july.He typically has absent seizures and has not had a grand mal seizure in many years.He was curious if the magnet activation actually caused him to have a grand mal seizure.He did mention that he started having absence seizure clusters prior to the grand mal seizure.His wife informed him that he got completely stiff solid like a board for about 20 seconds.They have never witnessed him having this type of seizure.No additional information has been received to date.

Event Description

Additional information was received that indicated that the magnet swipe was not believed to have caused the seizure and that there were external factors that contributed to the patient's new seizure type.It was stated that the patient was not having an increase in seizure frequency.No additional or 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: 8422767
• MDR Text Key: 138907067
• Report Number: 1644487-2019-00503
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/12/2019
• Device Model Number: 105
• Device Lot Number: 204270
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/19/2019
• Initial Date FDA Received: 03/14/2019
• Supplement Dates Manufacturer Received: 03/26/2019
• Supplement Dates FDA Received: 04/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2018
• 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 Age: 29 YR