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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problems Fall (1848); Seizures (2063); No Code Available (3191)

Event Date 04/01/2016

Event Type  malfunction  

Event Description

It was reported that a patient had high impedance on a follow-up visit with the physician that occurred on (b)(6) 2016.The patient also reported not feeling stimulation and an increase in seizures.In (b)(6), the patient had experienced a hard fall while hiking and the increase in seizures and the change in perception of the stimulation occurred after the fall.The seizure rate increased from 2-3 per month to 9 seizures during the month of april, after the fall.X-rays were sent to manufacturer for review.Based on the images provided, the source of the reported high impedance could not be determined.There did not appear to be any obvious lead discontinuities in the portion of the lead that could be visualized; however, part of the lead was difficult to assess due to the quality of the images.The presence of a micro-fracture in the lead could not be ruled out.Review of the x-rays showed inadequate strain relief.The patient underwent full revision surgery on (b)(6) 2016.Post-op system diagnostics showed impedance values within normal limits.No additional relevant information has been provided to date.

Event Description

The generator and lead were received for analysis.Analysis of the lead was completed on 06/17/2016.Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product.During the visual analysis what appeared to be pitting was observed on the connector pin surface.A definite cause for the pitting could not be determined based on the lead portion returned.The condition of the returned lead portion is consistent with that which typically exists 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 portion were performed, during the visual analysis, and no discontinuities were identified.Analysis of the generator was completed on 06/21/2016.Review of the ram/flash data downloaded from the pulse generator shows a possible indication of increased impedance; the ¿diagvinitialprechange¿ value of 2085 ohms, the ¿diagvinitialpostchange¿ value of 19121 ohms, and the time of change detection (b)(6) 2016.It is likely that the generator was tested with a test resistor after explant to confirm high impedance within the lead.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.There were no additional performance or any other type of adverse condition found with the pulse generator.

• 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: 5678328
• MDR Text Key: 47235169
• Report Number: 1644487-2016-01116
• 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
• Report Date: 05/03/2016

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: 07/31/2011
• Device Model Number: 302-20
• Device Lot Number: 200867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/03/2016
• Initial Date FDA Received: 05/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2008
• 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 Outcome(s): Required Intervention
• Patient Age: 43 YR