MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

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

Patient Problems Muscle Spasm(s) (1966); Seizures (2063)

Event Date 05/25/2018

Event Type  Injury  

Event Description

A week before a patient's battery replacement surgery, which was initially indicated to be a prophylactic upgrade replacement surgery, the patient's device reportedly stopped working and caused the patient to develop uncontrolled grand mal seizures and tense neck muscles.The patient was previously experiencing no problems or pain with her vns and it was noted that the device was working as intended with no impedance issues.The patient's battery replacement surgery occurred.It was stated that the device was discarded per hospital policy, and would therefore not be available for return for analysis.No additional, relevant information was received to date.

Event Description

The patient's seizures were reviewed through an epilepsy monitoring unit and it was determined that her seizure condition is psychogenic in nature.

• Brand Name: PULSE GEN MODEL 105
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 8620941
• MDR Text Key: 145409274
• Report Number: 1644487-2019-00959
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750054
• UDI-Public: 05425025750054
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

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: 04/14/2018
• Device Model Number: 105
• Device Lot Number: 203769
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 04/23/2019
• Initial Date FDA Received: 05/17/2019
• Supplement Dates Manufacturer Received: 07/19/2020
• Supplement Dates FDA Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR