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 Problem Depression (2361)

Event Date 11/14/2022

Event Type  malfunction  

Event Description

It was reported that a patient reported that their entire chest, from neck to below breasts, are black and blue, purple, and blue and green.Patient notes this has worsened their depression because they are so uncomfortable.No additional relevant information has been received to date.

Manufacturer Narrative

Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.

Event Description

Information was received that the subject met with the surgeon to discuss the bruising because it was more than anticipated.Surgeon informed her it was a result of the surgery.Subject stated they could see the lead under their skin and was not expecting this.Subject has very little body fat and this is believed to be the cause of the reported protrusion.No interventions are currently planned because there is little that could be done due to patient anatomy.Regarding the worsened depression, this was due to unexpected results from the surgery: bruising, lead visibility in the neck etc.Subject is very ¿body conscious¿ and was not expecting these results.As stated above, subject is very body conscious and did not like the results they observed after the surgery.As a result of the reported bruising and not receiving any response from calls to the surgeon, this increased the subject¿s anxiety.The subject stated that after their meeting that they felt much better just because things were explained and they had a much better understanding of what was happening and why.

• Brand Name: PULSE GEN MODEL 8103
• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 15949637
• MDR Text Key: 306073451
• Report Number: 1644487-2022-01581
• Device Sequence Number: 1
• Product Code: MUZ
• 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: Study,Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 8103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/14/2022
• Initial Date FDA Received: 12/09/2022
• Supplement Dates Manufacturer Received: 12/17/2022
• Supplement Dates FDA Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 62 YR