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

Model Number 105

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

Patient Problems Nausea (1970); Pain (1994); No Code Available (3191)

Event Date 08/11/2015

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary as the reported events were not related to the functionality of the device.

Event Description

It was reported that a patient has been experiencing nausea and pain since having the m105 generator implanted.She stated that the generator was too large for her small frame, as she weighs 105 pounds, and the generator is visible through her clothes.The patient also stated that the generator moves when she moves her arm.She was looking to receive a smaller generator as the m103 generator gave her no issues.Follow up with the surgeon's office confirmed that non-resorbable suture was used to secure the generator.It was further stated that a m103 device was placed in aug 2015 and that the surgeon's office had not heard from the patient in regards to nausea, pain, protrusion or migration.Attempts were made for follow-up with the psychiatrist's office.It was stated that the patient had spoken to the physician regarding a larger implant, but no other information was available.It could not be clarified if a model 103 device or model 105 device was implanted.It was stated that the patient was scheduled for explant surgery due to the reported events.No further relevant information was received to date.

Event Description

It was clarified that the patient had a vns replacement in 2015 to the larger m105 device.Due to the discomfort the patient was feeling, the device was removed in early september, stated to be due to the need for a mammogram.No further information was 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7921428
• MDR Text Key: 122147943
• Report Number: 1644487-2018-01730
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750054
• UDI-Public: 05425025750054
• 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
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/05/2017
• Device Model Number: 105
• Device Lot Number: 203245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 11/27/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/22/2015
• 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: 61 YR