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 Problem Unspecified Infection (1930)

Event Date 06/06/2019

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr? device evaluation is not necessary as infection is not related to the functionality or delivery of therapy of the device.

Event Description

Information was received from the doctor that indicated that the reason for generator replacement was that the patient had chronic skin infections and picked at he surgical site.It was indicated that it was fixed with replacement; however replacement surgery occurred after this information was received.Follow-up with the neurologist indicated that the reason for replacement was desire for new technology and the attending representative at the generator replacement surgery indicated that he did not know that the cause of the replacement was infection.The generator's device history records were reviewed and sterility of the product prior to release was verified.Product return and analysis is not needed as chronic skin infections are not related to the functionality of the product.No further relevant information has been received to date.

Event Description

The physician reported that the chronic skin infections began many years prior to the patient being implanted with the vns.He indicated that they were mild in nature and were neurodermatitis.He indicated that the infections around the vns were gone.No further 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: 8807476
• MDR Text Key: 151594209
• Report Number: 1644487-2019-01405
• Device Sequence Number: 1
• Product Code: LYJ
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/08/2016
• Device Model Number: 105
• Device Lot Number: 4082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/01/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/07/2014
• 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: 23 YR