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

Model Number 302-20

Device Problems Corroded (1131); Fluid/Blood Leak (1250); Fracture (1260)

Patient Problem Seizures (2063)

Event Date 11/13/2017

Event Type  malfunction  

Event Description

Report received that high impedance was observed on a patient's vns.When the patient was seen by the physician, she reported that her vns did not seem to be working for the "last two weeks".It was then interrogated where high impedance was found.Further information was received that the patient did not feel the vns stimulation which was why she believed the vns was not working.It was also reported that the patient presented with an increase in seizures due to the high impedance.The lead was later replaced.The surgeon reportedly did not noticed any gross visual lead fractures but did indicate that fluid was in the lead tubing.The explanted products were reportedly returned to the manufacturer but they have not been received to date.No further relevant information has been obtained.

Event Description

Further information was received that the explanted lead and generator were received by the manufacturer.Product analysis was later completed on the lead.Product analysis observed abraded openings and torn areas on the outer and inner silicone tubing.These openings provided a leakage path for dried remnants of what appeared to have once been bodily fluid to enter the inner and outer tubing.Additionally, two areas on the quadifilar coils were found to be broken.Scanning electron microscopy was performed and identified the areas as having extensive pitting which prevented identification of the coil fracture type.Pitting and residual material were observed on the coil surface.With the exception of the abraded open / torn areas and observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were noted.The set screw 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 other discontinuities were identified.An evaluation was not made on the portion of the lead that was not returned.No further relevant information has been received to date.

Event Description

Further information was received from product analysis on the generator.Visual analysis found no anomalies other than marks and discoloration associated with the normal implant and explant procedure.Both interrogation and system diagnostics were performed on the generator.Results showed communication was ok, lead impedance and current delivered were normal for all diagnostic tests performed.The generator output signal was monitored over 24-hours and no signs of variation in output signal were found.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The data from the generator was also reviewed the day of the first occurrence of high impedance could not be found from the data.It showed that the remaining voltage was slightly lower than expected based on the estimated charge consumed, but this was likely due to the generator being connected to a lead with high impedance.No other anomalies were seen with the generator.No further relevant information has been received to date.

• Brand Name: LEAD MODEL 302
• 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: 7137758
• MDR Text Key: 95807822
• Report Number: 1644487-2017-05060
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2006
• Device Model Number: 302-20
• Device Lot Number: 10960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/27/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 12/28/2017; 01/22/2018
• Supplement Dates FDA Received: 01/17/2018; 02/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2004
• 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 Outcome(s): Required Intervention
• Patient Age: 46 YR