MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

Model Number 302-20

Device Problem High impedance (1291)

Patient Problems Fatigue (1849); Depression (2361); No Code Available (3191)

Event Date 12/26/2017

Event Type  malfunction  

Event Description

It was reported via clinic notes received that the patient's mood had been lower the past few weeks.The patient felt that the vns was not working.Upon interrogation of the vns, it was indicated that the battery was near end of service and that high lead impedance was observed.The patient acknowledged passive suicidal ideations, increased sleep, decreased energy, and decreased interest/pleasure.The physician referred to patient for vns replacement surgery.No surgical intervention is known to have occurred to date.No additional relevant information has been received to date.

Event Description

Follow up with the physician's office revealed that the passive suicidal ideations, increased sleep, decreased energy, and decreased interest/pleasure were attributed to a relapse of depression caused by the loss of function of the vns.It was stated that the increase in depression was not as severe as the pre-vns baseline.

Event Description

The patient underwent vns generator replacement surgery.The generator was reported as completely depleted and unable to be interrogated.Upon running diagnostics on the new vns generator, high impedance was still observed.The surgeon decided not to replace the lead at the time.During attempts at product return for the explanted generator, it was revealed that the facility, historically, does not return explanted devices.

Event Description

It was reported by the patient that the replacement surgery had went well and that the vns seemed to be working well as any placebo effect would have worn off by this point.It was stated that the physician increased the output current due to the high impedance.The patient stated that the vns seemed to be working fine to him even prior to the settings increase.

Event Description

Follow up with the physician revealed that the patient was referred to vns lead replacement surgery to address the high impedance.X-rays were performed, but the images have not been reviewed by the manufacturer to date.No relevant surgery is known to have occurred to date.

Event Description

X-rays were received and reviewed by the manufacturer.The vns lead pin appeared to be fully inserted in the generator connector block and the vns generator feedthru wires appeared to be fully intact.A portion of the lead was behind the generator.The lead wires appeared to be fully intact at the connector pin and no gross lead fracture or sharp angles were observed in the visible portion of the lead.However, due to the image quality, the entire lead body could not be accurately assessed.No obvious cause for the high impedance could be identified, though the presence of a fracture in the portion of the lead excluded from the images or a micro-fracture could not be ruled out.It was reported that the surgeon did not wish to perform a vns lead revision at this time as the patient was not in any discomfort and was getting good therapeutic results.

Event Description

The patient was referred for surgery to correct the high lead impedance.The patient underwent vns replacement surgery.The surgeon had difficulty removing the lead due to scar tissue and only removed the top electrode in order to have room to implant the new lead above the existing lead.As such, product return is not expected as the lead remained implanted.

• 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: 7264867
• MDR Text Key: 99996322
• Report Number: 1644487-2018-00200
• Device Sequence Number: 1
• Product Code: MUZ
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2008
• Device Model Number: 302-20
• Device Lot Number: 1283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/18/2018
• Initial Date FDA Received: 02/12/2018
• Supplement Dates Manufacturer Received: 02/20/2018; 04/04/2018; 04/28/2018; 05/24/2018; 06/13/2018; 07/23/2018
• Supplement Dates FDA Received: 02/28/2018; 04/23/2018; 05/14/2018; 06/07/2018; 07/10/2018; 08/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2005
• 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: 72 YR