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 Dyspnea (1816); Hypoxia (1918); Seizures (2063)

Event Type  malfunction  

Event Description

It was reported that the patient's seizures had worsened following a change in settings.It was reported that the settings were changed due to the patient experiencing breathing problems since being implanted with vns.No additional or relevant information has been received to date.

Manufacturer Narrative

Sex; corrected data; initial mdr submitted incorrect data as it was known that the patient was a male at the time of submission.

Event Description

It was reported that the patient's settings were further adjusted.It was also reported that the breathing difficulties occur with stimulation and with exertion, and that the increased seizures is below pre-vns seizure rate.No additional or relevant information has been received to date.

Manufacturer Narrative

Describe event and patient code; corrected data; initial mdr inadvertently omitted data that was known prior to submission.

Event Description

It was reported that the patient desaturates at night due to the breathing difficulties.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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7775634
• MDR Text Key: 116859888
• Report Number: 1644487-2018-01378
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 09/19/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/02/2019
• Device Model Number: 106
• Device Lot Number: 204153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/13/2018
• Initial Date FDA Received: 08/12/2018
• Supplement Dates Manufacturer Received: 08/21/2018; 09/14/2018
• Supplement Dates FDA Received: 09/14/2018; 09/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 37 YR