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

Model Number 300-20

Device Problems High impedance (1291); Device Inoperable (1663)

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

Event Date 04/08/2014

Event Type  malfunction  

Event Description

It was reported that a vns patient received a high impedance warning during diagnostic testing and that the patient¿s generator was disabled as a result.Last successful diagnostic results were reportedly obtained seven (7) months earlier.Surgery has not occurred to date.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description

On (b)(6) 2014 it was reported that the generator and lead would be returned for product analysis.A full revision surgery had taken place on (b)(6) 2014 due to the high impedance.The generator and lead were received for product analysis on (b)(4) 2014.Product analysis is still underway and has not yet been completed.

Manufacturer Narrative

Only a portion of the lead was returned for analysis which did not reveal any anomalies.Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

Event Description

On august 18, 2014 product analysis was completed on the explanted generator.Results of diagnostic testing indicated that the battery status indicated ifi=no in the product analysis lab.The battery voltage was 2.895 volts (not at ifi) as measured during completion of the final electrical test.Electrical test results showed that the pulse generator performed according to functional specifications.There were no adverse functional, mechanical, or visual issues identified with the returned generator.The review of the device's internal memory showed the impedance went from 9799ohms to 12299ohms on (b)(6) 2014, both of which are high impedance.Product analysis was completed on the lead on 9/2/14.Except for slight observed pitting on the negative connector pin and one abraded outer tubing observation, there were no observed product related issues with the returned lead portions.Scanning electron microscopy images of the unmarked connector pin show that pitting or electro-etching conditions have occurred on the connector pin surface at the areas where reddish-brown deposits were noted.An energy dispersive spectrometry (eds) analysis performed on the sample of the reddish-brown deposits observed on the pin showed the presence of some elements typically observed on stainless steel 316/316l.The higher percentage of iron observed in this sample suggests that an oxidation process may have occurred.The exact impact of this condition on any on the reported "high impedance" allegation is unknown.Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.The outer silicone tubing is abraded open and the lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing of the second portion of the returned lead.No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion.

• Brand Name: BIPOL LEAD MODEL 300
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 3786843
• MDR Text Key: 16916395
• Report Number: 1644487-2014-01159
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2004
• Device Model Number: 300-20
• Device Lot Number: 6055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2002
• 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: 55 YR