MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problems Unspecified Infection (1930); Tissue Breakdown (2681)

Event Date 12/26/2018

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr? device evaluation is not necessary because the reported event "have" been determined as not related to vns therapy.

Event Description

It was reported that the patient¿s generator was exposed after their replacement incision had been opened during a bicycle accident.The patient¿s generator and a portion of their lead wire were removed.The patient was reported to have had an infection, and the infected encapsulation tissue was removed.The devices were discarded and will not be returned.Device history records were reviewed and the generator and lead were sterilized and passed all specifications prior to distribution.No additional or relevant information has been received to date.

Event Description

Clinic notes were received and the patient¿s infection was said to be well healed.No additional information is available.

• Brand Name: PULSE GEN MODEL 106
• 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: 8258460
• MDR Text Key: 133422301
• Report Number: 1644487-2019-00083
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/08/2020
• Device Model Number: 106
• Device Lot Number: 204629
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 4 MO
• Event Location: Other
• Date Manufacturer Received: 02/12/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/12/2018
• 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: 46 YR