MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Scratched Material (3020)

Patient Problems Wound Dehiscence (1154); Seizures (2063)

Event Date 05/04/2016

Event Type  Injury  

Manufacturer Narrative

Suspect medical device udi: (b)(4).

Event Description

It was reported that the generator site was open and the generator was exposed.The patient was recently implanted on (b)(6) 2016.The patient was then referred for surgery to irrigate the site and close the incision.Further follow-up found that the patient has a history of picking at his skin during a seizure.The patient reported to the neurologist that he had a seizure and afterwards the generator incision was found to be open.The patient underwent surgery where the incision site was irrigated with antibiotic solution and the incision was closed.The generator was not replaced during this surgery.No additional relevant information has been received to date.

Manufacturer Narrative

Device evaluated by mfr?, device evaluation is not necessary as infection is not related to the functionality or delivery of therapy of the device.

Event Description

It was reported that the patient's generator and lead were explanted due to infection.Device evaluation is not necessary as infection is not related to the functionality or delivery of therapy of the device no further relevant information has been received to date.

Manufacturer Narrative

Describe event or problem , corrected data: the manufacturer's device history records review for sterility was inadvertently omitted from supplemental mdr 1.Type of investigation, corrected data: (b)(4).

Event Description

The manufacturer's device history records of the lead and generator were reviewed.The sterility of the lead and generator prior to release was verified.

• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 5718792
• MDR Text Key: 47196380
• Report Number: 1644487-2016-01314
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/04/2018
• Device Model Number: 106
• Device Lot Number: 4697
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/09/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/21/2016
• 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: 41 YR