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 Paralysis (1997)

Event Date 02/08/2019

Event Type  Injury  

Event Description

It was reported that a patient involved in the (b)(6) study experienced left vocal cord palsy (paralysis) after vns device implant.The patient was provided medication due to the left vocal cord paralysis.No further relevant information has been received to date.

Event Description

It was reported that the patient's left cord vocal palsy was not recovered / resolved as previously reported.It was reported that the event was ongoing and that there were no actions taken.It was reported that the adverse event did not cause the patient to discontinue.No further relevant information has been received to date.

Event Description

It was reported that the patient's device was not turned on directly after their vns implant and that the generator stimulation was turned off prior to the day the vocal cord paralysis was reported.It was reported that the vocal cord paralysis experienced by the patient was likely caused by the surgical maneuvers during the implant.No further relevant information has been received to date.

Event Description

It was reported that the adverse event had recovered / resolved.No further relevant information has been received to date.

Event Description

It was reported that the patient's left vocal cord palsy had recovered / resolved.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
• 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: 8403939
• MDR Text Key: 138237817
• Report Number: 1644487-2019-00443
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/10/2020
• Device Model Number: 106
• Device Lot Number: 5972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2018
• 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
• Patient Age: 43 YR