MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-20

Device Problem Fracture (1260)

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

Event Date 08/16/2017

Event Type  malfunction  

Event Description

Report received that high impedance was found after performing system diagnostics on new generator in the operation room.The patient was scheduled for a generator replacement due to battery depletion, and the generator was unable to be interrogated.When the new generator was implanted and connected to the lead, a system diagnostic was run and showed high impedance.The lead was explanted.Further information was received that during the surgery, the lead pin was confirmed to be inserted into the generator properly.Generator diagnostics were also performed on the new generator and the results showed normal impedance.A review of the programming history did not indicate whether or not high impedance was seen prior to the replacement.Recent system diagnostics prior to surgery could not be provided by the patient's physician.The lead and generator were explanted and received by the manufacturer, but analysis has not been approved to date.No other relevant information has been provided to date.

Event Description

Product analysis was completed on the generator.The generator could not be interrogated due it reaching normal battery depletion.A review of the generator data showed a 26.3% change in impedance.The pre and post change impedance values were both normal.The data did not show the onset of high impedance as the battery became too depleted to perform automeasures for impedance.The measured battery voltage was consistent with the estimated charge consumed.No further relevant information has been received to date.

Event Description

Further information was received that product analysis was completed on the lead.The lead was returned in two portions.Visual examination showed one portion had stretched and kinked quadfilar coils.On this portion, set screw marks were present and white deposits were observed in various locations.Abrasions were also noted on the connector boot.Dried remnants of what appeared to be bodily fluids were inside the outer silicone tubing.Other abraded openings were seen along the outer tubing of this portion.On the second portion, white deposit was also seen.Besides typical markings and damage associated with explant, no visual anomalies were noted.No discontinuities were found during the continuity checks for the returned portions.However, there was a portion of the lead which included the electrodes which was not returned for analysis and an assessment on that portion could not be made.No further relevant information has been received to date,.

• 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: 6849884
• MDR Text Key: 85286047
• Report Number: 1644487-2017-04389
• 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: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2011
• Device Model Number: 302-20
• Device Lot Number: 200910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2008
• 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: 13 YR