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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problem No Code Available (3191)

Event Date 12/22/2014

Event Type  malfunction  

Event Description

Analysis of the returned lead portions was completed on 02/27/2015 and it identified pitting on the pin surface; reddish deposits on the pin surface were found with a high percentage of iron that suggests that oxidation may have occurred, but the impact of this condition cannot be determined.No other anomalies were identified in the returned lead portion.Note that since the electrode array portion was not returned for analysis, an evaluation cannot be made on that portion of the lead.Analysis of the generator was completed on 03/04/2015 proper functionality of the pulse generator was verified.The device provided the expected level of output current.The battery showed an ifi=no condition.The as-received internal device data showed that the last 25% change in the impedance value was estimated to have occurred during replacement surgery on (b)(6) 2015, where the impedance value changed from high lead impedance to a normal limits range.No adverse conditions were identified for the generator.

Event Description

It was reported that device diagnostics resulted in high impedance.It was reported that the patient had recently undergone generator replacement on (b)(6) 2014 for end of service.It was reported that device diagnostics in the operating room were within normal limits (2000 ohms).It was reported that the lead impedance increased gradually following surgery and that on (b)(6) 2014 the high impedance was first observed.It was reported that x-rays were scheduled and surgical revision was planned.No known surgical intervention has been performed to date.

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.Only a portion of the lead was returned for analysis which did not reveal any lead fractures.A lead fracture is suspected in the lead portion not returned.

Event Description

X-rays were taken and were reported by the physician to be unremarkable.It was reported that the patient underwent full revision surgery on (b)(6) 2015 to replace the lead.The generator was replaced prophylactically.The explanted devices were returned to the manufacturer.Analysis of the devices is currently underway.

Manufacturer Narrative

Describe event or problem; corrected data: the previously submitted mdr inadvertently did not include the assessment of the x-rays by the health professional.

• 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: 4430709
• MDR Text Key: 5341266
• Report Number: 1644487-2015-03660
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2011
• Device Model Number: 302-20
• Device Lot Number: 2205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2008
• 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: 12 YR