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

Model Number 302-20

Device Problem Low impedance (2285)

Patient Problem Seizures (2063)

Event Date 01/23/2015

Event Type  malfunction  

Event Description

It was reported that device diagnostics resulted in low impedance (<600 ohms) and that the patient has experienced worsening seizures.The patient was referred for lead replacement.The patient underwent lead replacement on (b)(6) 2015.It was reported that device diagnostics with the new lead and existing generator were within normal limits.The explanted lead has not been received for analysis to date.No additional relevant information has been received to date.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description

The explanted lead was returned for analysis on (b)(4) 2015.Product analysis for the lead was completed and approved on (b)(4) 2015.An analysis was performed on the returned lead portions and a condition was observed that could potentially contribute to the reported ¿low impedance / low impedance message, short circuit condition¿ (lead section) allegations.The bare and exposed conductive coils may be a contributing factor.Note that since a portion of the lead assembly including the electrodes was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Abraded openings were observed on the outer silicone tubing and both of the inner silicone tubes.The quadfilar coils appeared to be stretched, kinked and bare, in some areas.The abraded openings found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing.What appeared to be white deposits were observed in various locations.With the exception of the abraded openings, the condition of the returned lead portions is consistent with those that typically exist following an explant procedure.No other obvious anomalies were noted.The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified.

Manufacturer Narrative

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

• 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: 4531971
• MDR Text Key: 5544264
• Report Number: 1644487-2015-03918
• 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 Assistant
• Type of Report: Initial,Followup
• Report Date: 01/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2008
• Device Model Number: 302-20
• Device Lot Number: 1354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2005
• 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: 17 YR