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 Aspiration/Inhalation (1725); Dysphagia/ Odynophagia (1815); Dyspnea (1816)

Event Date 05/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient was having shortness of breath, ¿wrong roads to liquids at the passage¿, issues swallowing, and difficulty coughing up phlegm in their throat.These events occur with stimulation.The physician lowered the settings and was planning to disable the device.No additional or relevant information has been received to date.

Manufacturer Narrative

Brand name, corrected data: initial mdr inadvertently gave pulse gen model unknown.Model #, corrected data: initial mdr inadvertently did not provide model 106.Unique identifier (udi) #, corrected data: initial mdr inadvertently did not provide (b)(4).

Event Description

Settings and diagnostics from the patient¿s programming history were provided.The diagnostics provided were within normal limits.No additional or 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: 8668192
• MDR Text Key: 146973052
• Report Number: 1644487-2019-01069
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 09/18/2019

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: 07/10/2020
• Device Model Number: 106
• Device Lot Number: 204536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/10/2019
• Initial Date FDA Received: 06/04/2019
• Supplement Dates Manufacturer Received: 06/07/2019; 09/04/2019
• Supplement Dates FDA Received: 06/27/2019; 09/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2018
• 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: 28 YR