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

Model Number 302-20

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem Injury (2348)

Event Date 03/21/2014

Event Type  malfunction  

Event Description

An implant card was received indicating that the vns patient underwent lead and generator replacement surgery on (b)(6) 2014 due to lead discontinuity.Patient trauma is believed to have caused or contributed to the high impedance.X-rays were taken to verify lead pin insertion but were not provided for review.Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2011.The explanted generator and lead have been returned to the manufacturer where analysis 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.

Event Description

During the product analysis there were no anomalies found with the pulse generator.The generator performed according to functional specifications.During the visual analysis of the returned 215mm portion of the lead the (-) connector pin quadfilar coil appeared to be broken approximately 161mm from the end of the connector boot.Scanning electron microscopy was performed and identified the area as being mechanically damaged with pitting which prevented identification of the coil fracture type.During the visual analysis of the returned 197mm portion the (-) connector pin quadfilar coil appeared to be broken approximately 3mm from the end of the abraded open / torn / outer / inner silicone tubes.Scanning electron microscopy was performed and identified the area as being mechanically damaged with pitting which prevented identification of the coil fracture type.The area on one of the broken coil strands had evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture.Pitting was observed on the connector pin coil surface.It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.The abraded opening and slice mark found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing.The abraded openings found on the inner silicone tubes, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the inner silicone tubes.During the visual analysis of the returned 27mm portion the (+) white electrode and ribbon appeared to be partially embedded in what appeared to be dried body tissue.This condition may have prevented the (+) white electrode ribbon from coming in contact with the vagus nerve.With the exception of the observed discontinuities and the partially tissue-covered (+) white electrode and ribbon the condition of the returned lead portion is consistent with conditions 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, with no other discontinuities identified.Based on the findings, there is evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the reported event.Note that since one of the inner silicone tubes and quadfilar coils between the electrode bifurcation and anchor tether was not returned for analysis, an evaluation cannot be made on that portion of the lead.However, the positive electrode condition may have contributed to the reported event.

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: 3753816
• MDR Text Key: 4466923
• Report Number: 1644487-2014-01019
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 03/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2010
• Device Model Number: 302-20
• Device Lot Number: 200679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/06/2014
• Initial Date FDA Received: 04/16/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2007
• 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: 16 YR