MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Arrhythmia (1721); Dysphagia/ Odynophagia (1815); Pain (1994); Seizures (2063); Dysphasia (2195); Reaction (2414); No Code Available (3191)

Event Date 05/10/2012

Event Type  Injury  

Event Description

Initially, it was reported that the patient was scheduled for explant due to unknown reasons.It was later reported that the patient experiences multiple side effects which were worsened after generator replacement in 2012.It was noted that the patient experienced dysphonia with device activation and dysphagia to pills.The patient also noted atrial fibrillation with seizures, submandibular tenderness, gastroparesis, left-sided breast pain and left-sided jaw pain.It was noted that the symptoms continued after programming the device off.Attempts to obtain additional relevant information have been unsuccessful to date.No known surgical interventions have occurred to date.

Event Description

It was reported that the patient underwent vns explant.The explanting facility discarded the explanted devices; therefore, no analysis can be performed.

Event Description

Information was received from the patient that the patient continued to have the previously reported issues even after the vns was explanted and feels they are related to the lead coils being still implanted on her nerve.The patient reported she had increase in seizures, emotional outburst, burns on her brain, digestive issues, increased weight loss, and heart issues.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 105
• 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: 5526231
• MDR Text Key: 41164403
• Report Number: 1644487-2016-00642
• Device Sequence Number: 1
• Product Code: LYJ
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/14/2020

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: 02/28/2014
• Device Model Number: 105
• Device Lot Number: 202091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/29/2016
• Initial Date FDA Received: 03/25/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 11/19/2020
• Supplement Dates FDA Received: 06/12/2016; 07/21/2016; 12/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2012
• 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: 54 YR