MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

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

Patient Problem Headache (1880)

Event Date 10/22/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).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

It was reported that patient was experiencing painful stim, continuous stim, and lead protrusion.The np believes that these symptoms are due to the vns.All modes were disabled on the device outside of autostimulation.The symptoms persisted.All modes were disabled and the symptoms went away.Diagnostics are okay.Patient received x-rays, no anomalies were seen.The patient was referred to the neuro surgeon.Data was sent to the manufacturer for review in which no anomalies were detected.It is likely that the programmed heart rate detection threshold was too sensitive for the patient.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Manufacturer Narrative

B5.Describe event; corrected information ; initial mdr inadvertently omitted information known prior to submission d6b.If explanted, give date; corrected information ; initial mdr inadvertently omitted information known prior to submission f10.Adverse event problem; corrected information ; initial mdr inadvertently omitted information known prior to submission h6.Adverse event problem codes; corrected information ; initial mdr inadvertently omitted information known prior to submission.

Event Description

The patient was noted to be replaced prophylactically.The explanted device has not been received to date.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 1000
• 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: 15825066
• MDR Text Key: 303909456
• Report Number: 1644487-2022-01459
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 12/15/2022

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: 07/16/2020
• Device Model Number: 1000
• Device Lot Number: 204565
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/24/2022
• Initial Date FDA Received: 11/18/2022
• Supplement Dates Manufacturer Received: 11/21/2022
• Supplement Dates FDA Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2018
• 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
• Patient Age: 12 YR
• Patient Sex: Female