MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

Model Number 304-20

Device Problems Fracture (1260); Device Displays Incorrect Message (2591)

Patient Problem Seizures (2063)

Event Date 07/23/2015

Event Type  malfunction  

Event Description

It was reported that the patient presented to the er with increased seizures below pre-vns baseline.Upon diagnostics while in the er, low impedance was noted.It was stated that the low impedance message appeared indicating the impedance value was less than 600 ohms.The device was thus disabled.Review of the manufacturer's available programming history for this patient revealed that diagnostics on date of implant, (b)(6) 2011, revealed normal impedance values.It was reported that the patient had a status epilepticus event one night while the device was disabled, prior to the date of surgery.The patient underwent generator and lead replacement surgery on (b)(6) 2015 due to prophylactic generator replacement and low impedance.Diagnostics prior to surgery again revealed low impedance.It was also reported that a lead fracture was visually observed during the surgery.The explanted generator and lead have not be received by the manufacturer for analysis to date.

Event Description

The explanted generator and lead have been received by the manufacturer for analysis.However, analysis has not been completed to date.

Event Description

Analysis of the explanted generator and lead was completed.Analysis of the lead confirmed openings of both the outer and inner silicon tubing in adjacent areas, exposing conductive quadfilar coils and creating a potential short-circuit condition.Analysis of the generator revealed no anomalies.Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.There were no performance or any other type of adverse conditions found with the pulse generator.The downloaded data from the generator revealed that low impedance was observed (change from 207 ohms to 379 ohms on (b)(6) 2015).

• Brand Name: LEAD MODEL 304
• 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: 5009042
• MDR Text Key: 24631592
• Report Number: 1644487-2015-05500
• 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
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2014
• Device Model Number: 304-20
• Device Lot Number: 2786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2010
• 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): Hospitalization; Required Intervention
• Patient Age: 8 YR