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

Model Number 302-20

Device Problems Corroded (1131); Fracture (1260)

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

Event Date 07/01/2017

Event Type  malfunction  

Event Description

It was reported that the patient's device showed high impedance.The patient's device was also at a low battery indicator and was referred for a full revision surgery to address both events.Further information was received that the high impedance was first seen around the beginning of july according to the patient's mother.The physician's office had diagnostics recorded from earlier which were ok.There was no reported/observed traumatic event for the patient that could have led to the high impedance.No surgical intervention is known to have occurred to date.No additional relevant information has been received to date.

Event Description

Additional information was received that the patient had a full revision surgery to replace the lead and generator.It was stated that high impedance was observed during pre-op diagnostics.It was stated the surgeon implanted the new lead on the right vagus nerve due to too much scar tissue on the left side.The explanted products have not been received by the manufacturer to date.

Event Description

The products were received and analysis was completed on the generator.There were no adverse functional, mechanical, or visual issues identified with the returned generator.

Event Description

Product analysis was completed on the lead.The lead was returned in 3 portions with one tie down attached.The set screw marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.During continuity checks it was noted that the coil was broken close to the electrode bifurcation.The electrodes were not returned with this portion of the lead body.Sem was performed on the suspected coil break and it was noted that there was extensive pitting in the area making it not possible to identify the cause of the fracture.Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities 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: 6874986
• MDR Text Key: 86608537
• Report Number: 1644487-2017-04474
• 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,Followup
• Report Date: 12/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2011
• Device Model Number: 302-20
• Device Lot Number: 200931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/24/2017
• Initial Date FDA Received: 09/18/2017
• Supplement Dates Manufacturer Received: 09/19/2017; 11/02/2017; 12/04/2017
• Supplement Dates FDA Received: 10/12/2017; 11/27/2017; 12/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2008
• 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: 27 YR