MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 8103; GENERATOR

Model Number 8103

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

Patient Problems Ecchymosis (1818); Pain (1994)

Event Date 06/26/2020

Event Type  Injury  

Event Description

Patient presented to the er with a complaints of swelling at generator and electrode location noted to be definitely related to implant procedure.The patient was admitted to the hospital with subject for possible abscess at surgical sites.The surgeon went in 3 days later and removed hematomas at both locations.There was no abscess present at either site.The physician later saw the patient after surgery and the patient is doing much better.No other relevant information has been received to date.

Event Description

Patient presented with post-operative pain noted as definitely related to the implant procedure, and not related to stimulation or device.Patient was provided medication and the outcome is recovered/resolved.Additional information was provided regarding the hematoma.Medical or surgical intervention was performed to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function.Patient was also provided medication.

• Brand Name: PULSE GEN MODEL 8103
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 10326598
• MDR Text Key: 200424856
• Report Number: 1644487-2020-01000
• Device Sequence Number: 1
• Product Code: MUZ
• 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: 09/11/2020

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: Health Professional
• Device Model Number: 8103
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 07/27/2020
• Supplement Dates Manufacturer Received: 08/19/2020
• Supplement Dates FDA Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR