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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/24/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and system diagnostic results revealed high impedance (dc dc -7).The patient¿s device was not disabled following the high impedance observation.X-rays were taken and reported by the physician to be unremarkable.The patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity.The generator was replaced prophylactically.The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

Event Description

Operative notes were received indicating that the vns patient¿s generator was tested with a test resistor and generator diagnostic results showed normal device function.Analysis of the returned generator and lead was completed.There were no anomalies found with the pulse generator.The generator performed according to functional specifications.Analysis of the returned lead portion confirmed discontinuity of both positive and negative quadfilar coils in the electrode region.It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.

Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative

Device failure occurred, but did not cause or contribute to death.

• 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: 4207281
• MDR Text Key: 4965239
• Report Number: 1644487-2014-02851
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2005
• Device Model Number: 302-20
• Device Lot Number: 008996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2003
• 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: 38 YR