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 12/20/2018

Event Type  Injury  

Event Description

The patient reported that they were having issues with their vocal cord due to vns.The patient indicated that their symptoms were closer to vocal cord paralysis than voice alterations.These symptoms appeared following a recent prophylactic generator replacement surgery.System diagnostics were noted to be within normal limits following the replacement procedure.No other relevant information has been received to date.

Manufacturer Narrative

Outcomes attributed to adverse event, corrected data: follow-up report #1 inadvertently did not mark that the serious injury required surgical intervention.

Event Description

The physician confirmed that the patient was diagnosed with vocal cord paralysis.It was mentioned that the vns device was turned on directly after surgery; however, the neurologist noted that the cause of the vocal cord paralysis could not be determined.It was noted that the patient will be referred to surgery per ent request.No other 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: 8302063
• MDR Text Key: 134901810
• Report Number: 1644487-2019-00163
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/20/2019

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: 07/09/2020
• Device Model Number: 106
• Device Lot Number: 204557
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 02/04/2019
• Supplement Dates Manufacturer Received: 05/20/2019; 05/20/2019
• Supplement Dates FDA Received: 05/20/2019; 05/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2018
• 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; Required Intervention
• Patient Age: 44 YR