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

Model Number 106

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

Patient Problem Dizziness (2194)

Event Date 11/01/2019

Event Type  Injury  

Event Description

The patient's mother reported that the patient has been having vertigo since getting their settings adjusted in late october/early november.The patient was in the hospital as a result getting imaging done.Per the mother, there were no changes in medication to explain the side effect.No further relevant information has been received to date.

Event Description

It was reported by the hcp that the patient was not hospitalized, just given meds in the er.He had initial improvement with pt, but it eventually came back.The patient was no longer having symptoms after his medications were changed.Overall.The hcp believed that the vertigo was related most likely to his complex anti-epileptic med regimen as it improved with changes to them.Provided vns diagnostics were within normal limits.No further 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
• MDR Report Key: 11096663
• MDR Text Key: 224425836
• Report Number: 1644487-2020-01756
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: 02/02/2021

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: 09/15/2018
• Device Model Number: 106
• Device Lot Number: 5056
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/05/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 01/14/2021
• Supplement Dates FDA Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 41 YR