MAUDE Adverse Event Report: CYBERONICS, 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 01/01/2008

Event Type  Injury  

Event Description

It was reported that the patient's generator and lead would be explanted due to lack of efficacy.The patient was explanted.While following up with the office, the nurse read from the clinic notes that the patient was explanted because they had no clear benefit from the vns, the vns was causing the patient pain in the neck, and the device was turned off.The nurse could not clarify whether the explant was due to patient pain or just for lack of efficacy.The suspect product has not been received to date.No further relevant information has been received to date.

Manufacturer Narrative

Device available for evaluation?, corrected data: the initial report inadvertently omitted that the products were received.Describe event or problem, corrected data: the initial report inadvertently omitted that the products were received.

Event Description

It was reported by the physician that the patient's pain in neck was not the reason for explant.The pain reported was painful stimulation for which the patient's vns was disabled in 2010 for patient comfort.The explanted lead and generator were received.Product analysis was completed on the returned lead portion.The electrodes and part of the lead body were not returned so could not be evaluated.Product analysis identified an abraded opening in the lead outer tubing that caused fluid leaks into the outer tubing.However, product analysis found no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the patient's painful stimulation.The lead performed according to functional specifications with no obvious anomalies identified.Product analysis has not been completed on the returned generator, to date.No further relevant information has been received to date.

Event Description

Product analysis was completed on the returned generator.The generator was monitored for 24 hours in a simulated body temperature environment.The generator provided the intended output current for the entirety of the monitoring period.A comprehensive electrical evaluation showed that the device performed according to functional specifications.No anomalies were identified.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7042545
• MDR Text Key: 92363690
• Report Number: 1644487-2017-04806
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/14/2005
• Device Model Number: 302-20
• Device Lot Number: 9771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2003
• 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: 53 YR