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 Problems Chest Pain (1776); Neck Pain (2433); No Code Available (3191)

Event Date 12/22/2020

Event Type  Injury  

Event Description

It was reported that patient was experiencing generator migration.Two weeks later, the patient was feeling shocking sensations from the generator to the electrodes.Physician recommended binding her chest to help with the migration.The output current was turned off and the shocking stopped.Stimulation was later turned back on.Patient stated the shocking sensation returned, but is not constant.Patient has been referred for a full revision.Per the physician, the cause of the generator migration is not known.The cause of the shocking sensation was reported to be due to vns stimulation and device migration.The full revision was noted to be for patient comfort and to preclude a serious injury.No known surgery has occurred to date.No additional relevant information has been received.

Event Description

Patient had a explant surgery performed.It was indicated that patient may be replaced in the future, but no definitive decision has been made.The explanted generator has not been received to date.No additional relevant information has been received to date.

Event Description

It was confirmed that the patient only had their generator explanted.The patient leads were left implanted.No additional 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: 11251908
• MDR Text Key: 229361547
• Report Number: 1644487-2021-00116
• 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,Followup
• Report Date: 05/18/2021

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: 04/04/2019
• Device Model Number: 106
• Device Lot Number: 204103
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 01/29/2021
• Supplement Dates Manufacturer Received: 03/17/2021; 04/23/2021
• Supplement Dates FDA Received: 04/09/2021; 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR