MAUDE Adverse Event Report: CYBERONICS, INC. BIPOL LEAD MODEL 300

Model Number 300-20

Device Problems Corroded (1131); Fluid/Blood Leak (1250); Fracture (1260); High impedance (1291); Kinked (1339); Improper or Incorrect Procedure or Method (2017)

Patient Problems Seizures (2063); No Known Impact Or Consequence To Patient (2692)

Event Date 07/06/2015

Event Type  malfunction  

Event Description

It was reported that a physician first observed high impedance on a patient's device on (b)(6) 2015, but the physician did not program the device off until (b)(6) 2015, when high impedance was observed again.X-rays were taken, and there appeared to be an acute angle and kinks in the lead.Revision surgery is expected, but it has not occurred to date.

Manufacturer Narrative

Date received by manufacturer, corrected data: follow up report #1 inadvertently listed the wrong date.Follow-up type, corrected data: follow up report #1 inadvertently reported the type of report as additional information, instead of correction.Follow up report #1 inadvertently left off corrected data for relevant tests/laboratory data.

Event Description

The patient had surgery on (b)(6) 2015, and the generator was replaced.However, the lead impedance was still high after the original generator was replaced.The surgeon believed that the patient's vagus nerve was too short to implant another lead without removing the existing electrodes.The surgeon decided that he would not remove the lead and that the patient would have to have a vascular surgeon perform the lead revision surgery.The explanted generator was not available for return.No lead revision surgery has occurred to date.

Event Description

It was reported that the patient was seen again and still had high impedance.The patient had been having seizures, which was better than his pre-vns baseline, but he had been seizure free at one time.No surgical intervention has occurred to date.

Event Description

It was reported that the patient underwent a generator replacement and the generator was discarded following the surgery.The lead was left implanted and a diagnostic test showed that the high impedance continued with the new generator and existing lead.

Event Description

It was reported that the patient¿s generator which was implanted in (b)(6) 2017 was at end of service condition with high lead impedance still present.The physician assessed that the high lead impedance was related to the high lead impedance in the system.No additional surgical intervention has occurred to date for the high impedance.No additional relevant information has been received to date.

Event Description

The patient underwent lead and generator replacement surgery due to the high impedance.The explanted and lead and generator were received and are currently pending analysis.

Manufacturer Narrative

Corrected data: date received by manufacturer; 10/04/2017.This information was inadvertently reported incorrectly on mfg report #7.

Event Description

Analysis was completed on the returned generator and lead.Upon interrogation the battery indicator was found to be ifi = no.The generator was placed in a simulated body temperature environment and programmed to the ¿as received¿ parameter settings.During this time the output was monitored for more than 24 hours.There were no signs of variation in the output signal of the generator.The generator performed to functional specification.The lead was received in three pieces however the electrodes and tie downs were not received.Setscrew marks were observed on the marked connector pins.During visual analysis broken coils were identified in the lead in two different locations.Scanning electron microscopy showed one location to be mechanically damaged with no pitting and the type of fracture was unable to be identified.In the second location pitting was present which prevented the fracture type from being observed.It appeared that the fracture mechanism was stress induced.The pitting indicated that the fracture was present while stimulation was being supplied.Abraded openings were found in the inner and outer tubing which created a leakage path for fluid into the inner tubing.The analysis lab confirmed that a lead fracture had occurred.

• Brand Name: BIPOL LEAD MODEL 300
• 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: 5191856
• MDR Text Key: 30415111
• Report Number: 1644487-2015-06269
• 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,Followup,Followup,Followup,Followup
• Report Date: 11/29/2017

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: 01/21/2001
• Device Model Number: 300-20
• Device Lot Number: 19504C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/06/2015
• Initial Date FDA Received: 10/30/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided; 08/04/2017; 08/04/2017; 10/31/2017; 11/13/2017
• Supplement Dates FDA Received: 11/17/2015; 11/17/2015; 01/03/2016; 05/06/2017; 06/16/2017; 08/31/2017; 10/25/2017; 10/31/2017; 11/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/1999
• 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: 51 YR