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 Problems Discomfort (2330); Neck Pain (2433); Cramp(s) /Muscle Spasm(s) (4521); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/04/2024

Event Type  Injury  

Manufacturer Narrative

F10 health effect, clinical code: code e2402 utilized; appropriate term ¿lead pulling sensation¿ is not available.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 underwent a full revision due painful neck stimulation consistent with on times.Impedance was reportedly within normal limits, but with every interrogation the pain would intensify.During the procedure, the surgeon noted that the leads looked to be tugging on the nerve.No other relevant information has been received to date.

Event Description

New information was received reporting that per the physician, the cause of the painful stimulation is due to the presence of the vns device.The patient reportedly lost a lot of weight which the physician contributes as the cause of the migration which is the believed cause of the lead tugging sensation.The reason for the full revision was for both patient comfort and to preclude serious injury as patient reported intermittent popping sensation (already captured as painful stimulation), pain, and spasms.No other relevant information has been received to date.

Manufacturer Narrative

F10 health effect, clinical code: code e2402 utilized; appropriate term ¿generator migration¿ is not available f10 health effect, clinical code: code e2402 utilized; appropriate term ¿lead migration¿ is not available health effect - clinical code :e2402.

Manufacturer Narrative

F10: health effect - clinical code - e2402 - ¿lead pulling sensation¿ was used on initial mdr and was inadvertently included.It should not have been included because the code e1623 - "neck pain" was also used and captures the event reported more accurately.

• 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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 18646172
• MDR Text Key: 334618447
• Report Number: 1644487-2024-00110
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2024

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 Expiration Date: 05/19/2004
• Device Model Number: 302-20
• Device Lot Number: 6182
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 02/05/2024; 04/12/2024
• Supplement Dates FDA Received: 03/01/2024; 04/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2002
• 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
• Patient Sex: Female