MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 302

Model Number 302-20

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

Patient Problem Neck Pain (2433)

Event Date 05/02/2023

Event Type  Injury  

Manufacturer Narrative

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 the patient complained of painful, shocking sensation in the neck, with their newly replaced generator.After lowering the patient's parameters, the patient still felt discomfort, and the physician decided to disable the device (diagnostics were observed ok).The patient was referred for a possible lead revision.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

New information was received that the patient underwent a lead revision.A new lead was implanted and diagnostics were observed ok.The device was left off and the patient would follow up for titration the patient's vns was later turned on and the patient was able to tolerate the stimulation and did not feel any of the previously reported discomfort.The explanted lead has not been received to date.No other relevant information has been received to date.

Event Description

It was previously noted that the explanted lead is not available for return as the product is kept per the facility's policy.

Manufacturer Narrative

B5.Describe event; corrected information; supplemental mdr inadvertently omitted information known prior to submission.H6.Adverse event problem codes; corrected information; supplemental mdr inadvertently omitted information known prior to submission.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• 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: 16992943
• MDR Text Key: 315855322
• Report Number: 1644487-2023-00652
• Device Sequence Number: 1
• Product Code: MUZ
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2023

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: 04/29/2010
• Device Model Number: 302-20
• Device Lot Number: 200487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/02/2023
• Initial Date FDA Received: 05/24/2023
• Supplement Dates Manufacturer Received: 05/26/2023; 06/28/2023
• Supplement Dates FDA Received: 06/20/2023; 06/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2007
• 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; Other
• Patient Age: 66 YR
• Patient Sex: Female