MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302-20

Model Number 302-20

Device Problem High impedance (1291)

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

Event Date 07/29/2014

Event Type  malfunction  

Event Description

Clinic notes were received indicating that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and diagnostic results revealed high impedance (dc dc ¿ 7).X-rays were not taken.The patient was referred for surgery but no known surgical interventions have occurred to date.The notes showed normal device diagnostic results through (b)(6) 2013.

Event Description

It was reported that the patient underwent generator and lead replacement surgery.The generator was reported to be replaced prophylactically.It was reported that pre-operative system diagnostic resulted in high impedance (dc dc code - 7).Pre-operative device settings showed that the device had not been programmed off.The generator was replaced and device diagnostics again resulted in high impedance (>10,000 ohms).The lead was then replaced.Device diagnostics with the new vns system were within normal limits.The explanted generator and lead were received for analysis.Analysis is underway, but has not been completed to date.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).

Event Description

Analysis of the generator was completed on 10/14/2014.The generator performed according to functional specifications.During the product analysis there were no anomalies found with the pulse generator.Analysis of the lead was completed on 10/29/2014.A break was identified in the positive coil.Scanning electron microscopy images suggest pitting or electro-etching conditions at the suspected broken end of the positive coil of the second portion of the returned lead.Due to metal dissolution the fracture mechanism cannot be determined.Scanning electron microscopy images of the suspected positive coil (mate end to the second portion) located at the 3rd portion of the returned lead indicate a stress-induced fracture (fatigue) in at least three strands of the quadfilar coil.Also, the coils wires have mechanical distortions (smoothed surfaces) in the vicinity of the break.Note that since the electrode array portion 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 portions.

• Brand Name: LEAD MODEL 302-20
• 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: 4085398
• MDR Text Key: 4825818
• Report Number: 1644487-2014-02330
• 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,Followup
• Report Date: 08/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2008
• Device Model Number: 302-20
• Device Lot Number: 1169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2005
• 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: 39 YR