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

Device Problem Low impedance (2285)

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

Event Date 09/22/2015

Event Type  malfunction  

Event Description

It was reported that the patient has low impedance seen on a system diagnostics test on (b)(6) 2015.Good faith attempts for further information from the physician were unsuccessful.Although surgery is likely, it has not occurred to date.The lead product information cannot be obtained as the implanting hospital will not give out this information.

Event Description

On 10/12/15 it was reported that the patient underwent a full revision that day.During surgery, the surgeon noticed the lead wire insulation had pulled away from the lead wire immediately next to the generator header.This resulted with the lead wire being in direct contact with body tissue.The surgeon stated that he could not remove the lead pin from the header of the generator.The explanted lead and generator were returned for product analysis on 10/14/15.Product analysis is still underway and has not yet been completed.

Event Description

On (b)(6) 2015 the physician reported that the low impedance was first observed on (b)(6) 2015.There was no reported patient manipulation or trauma and the patient has not experienced clinical symptoms that are believed to be related to the low impedance.X-rays were taken but have not been sent to the manufacturer for review to date.

Event Description

Product analysis was completed on the generator on (b)(4) 2015.Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator铠output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.Magnet activations performed during output monitoring (at a distance of one-inch, spacer block, from the generator), demonstrate the appropriate magnet output for the programmed settings.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications; there were no performance or any other type of adverse conditions found with the pulse generator.Product analysis was completed on the leads on (b)(4) 2015.An analysis was performed on the returned lead portions and bare and exposed conductive coils may be a contributing factor condition that could potentially contribute to the reported low impedance.During the visual analysis of the returned 389mm portion the connector boot / inner silicone tubes appeared to be torn / pulled apart in half (at the end of the connector ring) with the quadfilar coils bare, exposed and stretched in between.During the visual analysis of the returned 56mm portion the (+) white electrode inner silicone tubing appeared have been melted through and the quadfilar coil appeared to be slightly melted.Additional melted areas were observed on both of the inner silicone tubes.Based on the obvious signs of mechanical damage on the inner silicone tubes and quadfilar coil, it is possible the thermally-damaged coil was exposed to a high temperature device such as a cauterizing tool (electrosurgical unit) during the explant of this lead (damaged coil, not a break).The abraded opening found on the outer silicone 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 inside the outer silicone tubing.For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process and the torn ends of the connector boot / outer / inner silicone tubes at the end of the connector ring.With the exception of the abraded opening and torn / pulled apart connector boot / inner silicone tubes, 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.

• Brand Name: LEAD MODEL UNKNOWN
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• 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: 5144333
• MDR Text Key: 28462301
• Report Number: 1644487-2015-06094
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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: 5 YR