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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problem Diarrhea (1811)

Event Date 02/19/2014

Event Type  malfunction  

Event Description

It was reported that during an office visit on (b)(6) 2014, the vns patient¿s generator was tested and the diagnostic results revealed high lead impedance (dc dc ¿ 7).When asked whether trauma or manipulation of the device occurred prior to the observation of high lead impedance, the nurse indicated that the patient believes that the high impedance was due to a violent sickness and diarrhea.No known interventions have occurred to date.Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2011.

Event Description

It was reported that the patient underwent generator and lead explant.An implant card was received indicating that both the generator and lead were replaced on (b)(6) 2014.The generator and lead were returned for analysis.Analysis is underway, but has not been completed to date.

Event Description

Analysis of the returned generator and lead was completed.The generator performed according to functional specifications.There were no anomalies found with the pulse generator.The returned lead assembly has dried remnants of what appear to have once been body fluids inside the inner silicone tubing.No obvious point of entrance was noted other than the end of the returned lead portion.Radiographic examination of the negative coil of the returned lead portion shows a suspected negative coil torn at the pin crimp.Scanning electron microscopy images of the negative coil show that a stress-induced fracture (due to tensional forces exerted on the lead¿most likely at explant) has occurred in the negative coil strands in vicinity of the pin crimp.This observed discontinuity does not appear to be related to the high impedance allegation as this is an explant-related event.Note that since a significant 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.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

Manufacturer Narrative

Device manufacturing records and available programming and diagnostic history were reviewed.Review of manufacturing records for the lead confirmed all quality tests were passed prior to distribution.Device failure is suspected, but did not cause or contribute to a death or serious injury.

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.

• Brand Name: LEAD MODEL 302
• 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: 3692232
• MDR Text Key: 4300259
• Report Number: 1644487-2014-00714
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2009
• Device Model Number: 302-20
• Device Lot Number: 1538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2014
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 05/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2006
• 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: 47 YR