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 Wound Dehiscence (1154); High Blood Pressure/ Hypertension (1908); Swelling (2091)

Event Date 05/14/2018

Event Type  Injury  

Event Description

It was reported from the patient that she had high blood pressure after surgery.She took blood pressure pill and it got better.She also says the incision came apart at some point, but was put back together.It is unclear which incision she is referring to.She states her incision on her chest is red and swollen.No additional or relevant information has been received to date.

Event Description

The physician stated that the patient has a history of anxiety, depression and obsessive compulsive disorder.For the allegation that the incision site had opened up post-surgery, he stated that it did not and the patient did not go back to surgery for this.The physician indicated no infection and healing well when asked about the redness and swelling at the generator site.Patient reported she was doing well post op (b)(6) 2018.No additional or 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
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7566864
• MDR Text Key: 109996495
• Report Number: 1644487-2018-00927
• Device Sequence Number: 1
• Product Code: LYJ
• 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,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 07/23/2018

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: 01/29/2020
• Device Model Number: 106
• Device Lot Number: 204373
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 06/04/2018
• Supplement Dates Manufacturer Received: 06/29/2018
• Supplement Dates FDA Received: 07/23/2018
• Date Device Manufactured: 02/09/2018
• 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): Other; Required Intervention
• Patient Age: 56 YR