MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

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

Patient Problems Headache (1880); Muscle Spasm(s) (1966); No Code Available (3191)

Event Date 10/30/2018

Event Type  Injury  

Event Description

It was reported that the patient was experiencing side effects such as voice loss/ alterations, tightening of the neck muscles, the patient¿s jaw moving more, and headaches.The patient wished to have the device removed and was referred for surgery.No known surgical intervention has occurred to date.No additional or relevant information has been received to date.

Manufacturer Narrative

Date user facility or importer became aware of event: incorrect date previously reported on initial mdr as 11/01/2018.Correct date is 10/31/2018.

• Brand Name: PULSE GEN MODEL 102
• 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: 8104539
• MDR Text Key: 128383096
• Report Number: 1644487-2018-02143
• Device Sequence Number: 1
• Product Code: MUZ
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/21/2019

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: 02/07/2008
• Device Model Number: 102
• Device Lot Number: 015424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 11 YR
• Event Location: Other
• Initial Date Manufacturer Received: 11/01/2018
• Initial Date FDA Received: 11/26/2018
• Supplement Dates Manufacturer Received: 06/21/2019
• Supplement Dates FDA Received: 06/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2006
• 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): Required Intervention
• Patient Age: 58 YR