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 Ecchymosis (1818); Edema (1820); Unspecified Infection (1930); Pain (1994)

Event Date 08/01/2020

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary because the reported event has been determined as not related to vns therapy.(b)(4).

Event Description

Patient was admitted into the hospital and given medication due to their chest incision site opening up, infection, localized chest pain and drainage from the chest incision site.There was also some note redness and swelling around the generator site.Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device.Design history record review for the generator performed.The generator was confirmed to have been sterilized prior to distribution into the field.The device passed all specifications.No other relevant information has been received to date.

Event Description

Information obtained from the physician that the reported events for the patient all stemmed from a fall that the patient had.The fall caused pain which lead to fluid drainage, redness and swelling.The patient was taken into surgery for exploration, irrigation, drainage, closure of infected vagal nerve stimulator pocket and hematoma.The patient was then taken back into surgery to have their vns device removed due to increased pain and fevers in their chest area.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 10521944
• MDR Text Key: 206536432
• Report Number: 1644487-2020-01187
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/20/2018
• Device Model Number: 106
• Device Lot Number: 5093
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 33 YR