MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

Model Number 302-20

Device Problems Break (1069); Corroded (1131); Fracture (1260); High impedance (1291); Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/30/2016

Event Type  malfunction  

Event Description

It was reported that a patient had full revision surgery due to battery depletion.It was later reported that the lead was replaced due to the electrode being detached from the nerve.The explanted generator and lead were received on 07/05/2016.Analysis of the generator identified that the device exhibited current consumption rates that are within specification, thereby demonstrating normal battery depletion to an end-of-service condition.The electrical performance of the generator were used to conclude that no anomalies exist and the eos condition is an expected event.The module performed according to functional specifications.There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.The explanting surgeon confirmed that the lead was not detached from the nerve.High impedance was identified, and there was fluid inside the outer tubing that brought the surgeon to believe that the lead wires had been compromised.Analysis of the lead identified two lead breaks and corrosion at the break locations.Due to wear at one of the break locations, the fracture mechanism could not be determined.The other break appeared to be due to stress/mechanical damage.The electrodes were not returned for analysis, so a complete evaluation could not be performed on the entire product.With the exception of the observed discontinuity the condition of the returned lead portions was consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were noted.

• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5821251
• MDR Text Key: 51345704
• Report Number: 1644487-2016-01685
• 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: Health Professional
• Type of Report: Initial
• Report Date: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2006
• Device Model Number: 302-20
• Device Lot Number: 011354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2004
• 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 Age: 33 YR