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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problem Seizures (2063)

Event Date 07/19/2016

Event Type  malfunction  

Event Description

It was reported that a patient had high impedance on a diagnostic test.The patient also reported an increase in seizures, even though it was noted that the patient's seizure rate was never completely controlled.A chest x-ray was performed, but due to the patient's body habitus, the view was limited.No further relevant information has been received to date.No known surgical intervention has occurred to date.

Event Description

The patient had a full replacement on (b)(6) 2016.The post-op lead impedance was within normal limits.The explanted products were reportedly discarded after surgery.

Event Description

The explanted lead was returned in two portions and an analysis was completed on the two lead portions.A lead coil break was identified approximately 2mm from the electrode bifurcation.Due to extensive pitting, the coil fracture type could not be identified.Low magnification scanning electron microscopy found characteristics typical of lead discontinuity.Two set screw marks were found on the connector pin, indicating that at one point in time, a good mechanical and electrical connection was present.Other than the observed lead discontinuity, the conditions of the returned lead portions were consistent with conditions typical of an explant surgery.The explanted generator was returned and product analysis was performed.The generator was found to pass all electrical and functional specifications.The analysis of the generator from the pa lab concluded that no abnormal performance or any other type of adverse condition was found.

• 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: 5841165
• MDR Text Key: 51965070
• Report Number: 1644487-2016-01732
• 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
• Report Date: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/23/2009
• Device Model Number: 302-20
• Device Lot Number: 1545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2006
• 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 Outcome(s): Required Intervention
• Patient Age: 60 YR