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 Erythema (1840); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Impaired Healing (2378)

Event Date 09/02/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient's incision has not healed completed since vns implant.Clinic notes dated (b)(6) 2015 note that the patient returns with concerns with her incision.It was noted that the patient experiences pain in the left chest and neck following activation of vns therapy.The patient developed a redness and hypersensitivity over both the generator and lead incisions and appears to be having a site reaction to the sutures.The patient was given bactrim ds and norco for the pain.The patient was advised to use dry heat to the chest wall.No additional relevant information has been received to date.

Event Description

Clinic notes dated (b)(6) 2017 were received from the patient's neurologist.The notes indicated that the patient's incision site showed fair healing in the neck.Per the notes, the neck incision was still a bit red and the stitch was palpable.The notes also indicated that the medial and lateral ends of the patient's generator incision site still showed incomplete healing and redness with dried purulence that was suggestive of previous infection.The patient had mild tenderness to palpitation of the chest.The device history records were reviewed for the lead and generator and revealed the devices met all specifications for sterility prior to release for distribution.No additional 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: 5199270
• MDR Text Key: 30327816
• Report Number: 1644487-2015-06326
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/20/2018

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: 07/02/2017
• Device Model Number: 106
• Device Lot Number: 4407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/09/2015
• Initial Date FDA Received: 11/03/2015
• Supplement Dates Manufacturer Received: 05/30/2018
• Supplement Dates FDA Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2015
• 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: 39 YR