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

Model Number 302-20

Device Problems Hole In Material (1293); Low impedance (2285); Scratched Material (3020)

Patient Problem No Code Available (3191)

Event Date 12/10/2006

Event Type  malfunction  

Event Description

Information was received indicating that low lead impedance was repeatedly observed via system diagnostics with a new pulse generator and a prior implanted lead during a generator replacement surgery.The surgeon verbally reported that the lead looked odd.It is unknown if generator diagnostics were performed with a test resister to test the generator's ability to accurately measure impedance.The physician did not replace the lead and the patient is being referred for a revision surgery.Subsequently received operative notes indicate that the physician observed a significant gap (opening) in the silicone insulation of the lead and attributed the low impedance to this condition.Pictures were taken of the lead and submitted and show possible, but inconclusive, insulation abrasion.A review of programming history with the prior device indicates system diagnostics lead impedances ranging from 0 to 2 with a decrease from 2 to 0 for the last several years of the available date.System diagnostic data from the date of replacement surgery with the prior pulse generator indicates dcdc 0, a warning of low lead impedance and impedance value <600 ohms.Attempts for additional relevant information have been unsuccessful to date and no known surgical interventions have occurred to date.

Event Description

The patient underwent lead explant and replacement on (b)(6) 2015.The surgeon left the electrode portion of the lead implanted and the new lead electrodes were placed above the former electrodes.It was observed that the lead insulation was broken down.No pre-operative device check was performed.The explanted lead has not been received by the manufacturer to date.

Event Description

The explanted lead was returned to the manufacturer.Product analysis confirmed abraded openings of the outer and inner silicone tubes in adjacent areas, exposing the conductive quadfilar coils and creating a potential short-circuit condition.A break of the positive coil in the electrode region of the returned lead was also observed.It is unknown if the break occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces.With the exception of the discontinuity and abraded openings, the condition of the returned lead portions is consistent with those that typically exist following an explant procedure.No other obvious anomalies were noted.Note that since a portion of the lead assembly (body), including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

Manufacturer Narrative

(b)(4).

• 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: 5275057
• MDR Text Key: 33367312
• Report Number: 1644487-2015-06644
• 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: 11/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2006
• Device Model Number: 302-20
• Device Lot Number: 010182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2004
• 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: 9 YR