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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Device Problems Insulation; Hole In Material; Low impedance; Scratched Material
Event Date 12/10/2006
Event Type  Malfunction  
Manufacturer Narrative

 
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).

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
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 Key5275057
Report Number1644487-2015-06644
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup,Followup,Followup
Report Date 11/13/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/08/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2006
Device MODEL Number302-20
Device LOT Number010182
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/29/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/29/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/09/2004
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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