MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

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

Patient Problems Itching Sensation (1943); Pain (1994); No Code Available (3191)

Event Date 09/27/2018

Event Type  Injury  

Event Description

It was reported that the patient's generator has moved laterally almost into the axilla and is causing itching and pain.Information was obtained from the implanting physician that absorbable sutures, 2.0 prolene, were used during the implant procedure.No additional relevant information has been received to date.No surgical intervention is known to have occurred to date.

Manufacturer Narrative

Describe event or problem: follow- up report #1 inadvertently did not include that the generator was returned.Device available for evaluation?: follow- up report #1 inadvertently did not include that the generator was available for evaluation and the date returned.

Event Description

The generator has been received into analysis.

Manufacturer Narrative

Device evaluation is not necessary because the reported events have been determined as not related to vns therapy.

Event Description

Information was received that the patient's generator was replaced.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• 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: 7994752
• MDR Text Key: 124679713
• Report Number: 1644487-2018-01891
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750030
• UDI-Public: 05425025750030
• 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,Followup
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/23/2016
• Device Model Number: 103
• Device Lot Number: 4123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/11/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/23/2014
• 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: 18 YR