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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problem Fall (1848)

Event Date 01/30/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient¿s device was tested and diagnostic results revealed high lead impedance (impedance value >= 10,000 ohms) during an office visit on (b)(6) 2014.The neurologist did not have the patient¿s device programmed off at the time.The patient had several falls but no other trauma was reported.Additional information was received stating that the neurologist had the patient¿s device programmed off during an office visit on (b)(6) 2014.X-rays will not be provided to the manufacturer for further review.The patient underwent generator and lead replacement surgery on (b)(6) 2014.The generator was replaced prophylactically.Diagnostic results with the replacement generator and existing lead showed high lead impedance (impedance value >= 10,000 ohms).The surgeon did not observe an evidence of patient manipulation of the device.Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012.Attempts to have the product returned for analysis were made but have been unsuccessful to date.

Event Description

The explanted generator and lead were returned to the manufacturer for analysis.The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted except for the half set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time.Additional setscrew marks found on the connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.Abrasions were observed on the connector boot and outer silicone tubing but did not penetrate.The quadfilar coils appeared to be stretched, wavy and spiraled in some areas.The outer silicone tubing appeared to be compressed in some areas.The ends of the out/inner silicone tubes and quadfilar coils appeared to be cut.Incisions were made to allow for continuity checks.Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified.Based on the findings, there is no evidence to suggest a discontinuity in the returned portion of the device which may have contributed to the reported high impedance.Note that since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Analysis of the returned generator is currently underway.

Manufacturer Narrative

Review of the available programming and diagnostic history.Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative

Only a portion of the lead was returned for analysis which did not reveal any anomalies.Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

Event Description

Analysis of the returned generator was completed.Electrical test results showed that the pulse generator performed according to functional specifications.There were no adverse functional, mechanical, or visual issues identified with the returned generator.Review of the as-received internal device data showed that the last 25% change in the impedance value was on (b)(6) 2014, where the impedance value changed from a normal limits range to high lead impedance.

Manufacturer Narrative

Date of event, corrected data: additional information indicates event occurred on (b)(6) 2014.

Event Description

The explanted lead and generator will reportedly not be returned for analysis due to the medical facilities policy on explants.

• 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: 3750559
• MDR Text Key: 4468924
• Report Number: 1644487-2014-01000
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2011
• Device Model Number: 302-20
• Device Lot Number: 200861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2008
• 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: 24 YR