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 Edema (1820); Fever (1858); Unspecified Infection (1930)

Event Date 09/21/2019

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr?, no, device evaluation is not necessary because the reported events have been determined as not related to vns therapy because they are related to the implantation procedure.

Event Description

It was reported that a patient was experiencing fever, neck swelling, and infection.The patient was provided antibiotics for treatment.These events were determined to have a causal relationship with vns implantation surgery.Product records for the patient's generator and lead were reviewed and sterilization for both products was verified.No additional information has been received to date.

Manufacturer Narrative

Event description; corrected data; it was found that the events contained in this report were duplicate to those contained in manufacturer report #1644487-2019-02104.Any additional information received for the events in question will be submitted under #1644487-2019-02104.

Event Description

It was found that the events contained in this report were duplicate to those contained in manufacturer report #1644487-2019-02104.Any additional information received for the events in question will be submitted under #1644487-2019-02104.

• 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: 9251661
• MDR Text Key: 164158808
• Report Number: 1644487-2019-02083
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750030
• UDI-Public: 05425025750030
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2019

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: 03/05/2021
• Device Model Number: 103
• Device Lot Number: 204877
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/04/2019
• Initial Date FDA Received: 10/29/2019
• Supplement Dates Manufacturer Received: 11/21/2019
• Supplement Dates FDA Received: 11/21/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/16/2019
• 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: 55 YR