MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

Model Number 302-20

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

Patient Problems Neck Pain (2433); Shock from Patient Lead(s) (3162); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/01/2008

Event Type  Injury  

Manufacturer Narrative

F10 health effect, clinical code: code e2402 utilized; appropriate term ¿protrusion¿ is not available.- protrusion to capture incidents of a device being visible under the skin.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 by the patient that they began experiencing the neck bulge at the electrode site during magnet stimulation following a recent fall.During explant surgery which previously was not indicated to be intervention for the adverse events, it was found that the electrodes were not attached to the nerve and was improperly implanted therefore was possibly stimulating to an unintended site.Training has already been provided to the implanting surgeon.Lead was received and product analysis was completed in mfr report # 1644487-2008-01149.Product analysis for the returned lead was completed.Note that a large portion of the lead assemble including the electrodes was not returned for analysis.Continuity checks of the returned lead portion were performed, during visual analysis no other discontinuities were identified.Patient later reported that the device was explanted due to the experienced severe pain alongside their neck bulging during magnet stimulation.It is concluded this intervention was also due to the protrusion.This surgery was not previously reported to be due to the adverse events.No other relevant information has been received to date.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 17783025
• MDR Text Key: 323859265
• Report Number: 1644487-2023-01361
• 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: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2009
• Device Model Number: 302-20
• Device Lot Number: 1509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2009
• Event Location: Other
• Date Manufacturer Received: 08/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2006
• 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: 26 YR
• Patient Sex: Female