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 Problems Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/28/2023

Event Type  Injury  

Event Description

It was reported that the patient's device was noted to be pulling initially.It was later reported that the patient was scheduled to have their device repositioned due to suspected migration.Device evaluation is not necessary because the reported event has been determined to be related to the functionality of the device.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Manufacturer Narrative

F10 health effect, clinical code: code e2402 utilized; appropriate term ¿migration¿ is not available.(note that although migration is an available medical device problem code, in this report¿s context, the migration does not reflect a problem with the functionality or delivery of therapy of the device.Therefore, a device problem code does not adequately capture the patient¿s adverse event.) h3.Device evaluated by mfr? code 81 - device evaluation is not necessary because the reported event has been determined to be related to the functionality of the device.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

The patient also reported pain with the migration reported prior to the revision surgery.

Manufacturer Narrative

B5.Describe event; corrected information ; corrected information; sup mdr #1 inadvertently omitted information known prior to submission.B6.Relevant tests/laboratory data, including dates ; corrected information; sup mdr #1 inadvertently omitted information known prior to submission.F10.Adverse event problem (refer to coding manual); corrected information; sup mdr #1 inadvertently omitted information known prior to submission.

Event Description

Patient manipulation is noted to be the cause of the lead pulling sensation and migration.The surgery was indicated to be due to patient comfort only.The lead is noted to not be protruding.It was later reported that surgery completed.During the procedure, the generator was moved about an inch medial to the right and tied it down.The generator was retested and the impedance was okay.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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 18826346
• MDR Text Key: 336779722
• Report Number: 1644487-2024-00257
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2024

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 Model Number: 1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 02/08/2024
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: Not provided; 03/28/2024
• Supplement Dates FDA Received: 03/28/2024; 03/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/17/2023
• 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: 17 YR
• Patient Sex: Female