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

Model Number 300-20

Device Problem High impedance (1291)

Patient Problems Seizures (2063); Inadequate Pain Relief (2388)

Event Date 01/06/2016

Event Type  malfunction  

Event Description

Clinic notes for a visit dated (b)(6) 2016 were received which observed high impedance on the patient¿s vns system.The patient¿s generator was previously replaced prophylactically on (b)(6) 2015.The patient¿s father estimates 10 partial seizures since the last visit.It was reported that the magnet rescue is no longer working where it usually works for the patient.Interrogation data showed 25 magnet activations had occurred.Side effects were denied.Vimpat was increased as it was stated the patient is not receiving adequate vns stimulation, however the patient was not satisfied with seizure control and side effects.No settings changes were made.The patient was referred for surgery.Follow-up to the company representative revealed that the implant case was covered and no high impedance was observed from that surgery.Review of the available programming history in the manufacturer¿s in-house database for the previously implanted generator revealed that diagnostics with the suspect lead were within normal limits on (b)(6) 2014.No additional information has been received to-date.No known surgery has occurred to-date.

Manufacturer Narrative

Event description, corrected data: information relevant to the suspect device was inadvertently not included on supplemental report #01.

Event Description

Product analysis was completed for the previous generator (b)(6) 2016.Review of the downloaded data revealed the last >25% change in impedance was on (b)(6) 2015, after the date of surgery on (b)(6) 2015.The lead impedance value prior to the change was within normal limits of 2241 ohms.There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description

Follow-up to the physician's office revealed that at the (b)(6) 2015 replacement surgery, the generator was interrogated and found to have good impedance.It was not provided whether the high lead impedance was with the previous generator or the replacement generator.

Event Description

It was reported the patient had generator and lead replacement surgery.The explanted product is to be returned for complete product analysis, but has not been received to date.

Event Description

The explanted products were received 05/16/2016.Analysis was completed for the returned generator 06/07/2016.Results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.The device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment.Results showed no signs of variation in the generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.Magnet activations performed during output monitoring demonstrate the appropriate magnet output for the programmed settings.The generator diagnostics were as expected for the programmed parameters.A comprehensive automated electrical evaluation showed that the generator performed according to functional specifications.The battery, measured 2.995 volts during completion of the final electrical test and shows an intensified follow-up indicator=no condition.The downloaded data revealed that 5.315% of the battery had been consumed.There were no performance or any other type of adverse conditions found with the pulse generator.Review of the downloaded data from the generator indicated the last >25% change in impedance showed high impedance was present the date of explant (b)(6) 2016.

Event Description

Analysis was completed for the lead.Four sets of setscrew marks were seen on the marked connector pin providing evidence that proper contact between the setscrew and the connector pin existed at least once.Scanning electron microscopy images of the marked connector pin show that pitting or electro-etching conditions have occurred on the pin surface.Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.No discontinuities were identified within the returned lead portions.A tear opening was noted on the outer silicone tubing at approximately 3.2cm and 17.3cm from the end of the connector bifurcation.The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing.No obvious point of entrance was noted other than the identified tubing openings and the cut ends of the returned lead portions.A suture constricting the lead body was removed and abrasions due to its presence were noted at this location.Another abrasion most likely caused by the presence of a suture constricting the outer silicone tubing were noted.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.

• 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: 5410173
• MDR Text Key: 38116620
• Report Number: 1644487-2016-00225
• 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: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2001
• Device Model Number: 300-20
• Device Lot Number: 23852C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/1999
• 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 Outcome(s): Required Intervention
• Patient Age: 29 YR