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

Model Number 302-20

Device Problems Corroded (1131); Fracture (1260)

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

Event Date 07/02/2016

Event Type  malfunction  

Event Description

It was reported that the patient's device had high impedance.The physician programmed the output current off and ordered x-rays.The patient was referred for full revision surgery.No surgical intervention has occurred to date.

Event Description

Further information was received that the patient received a full revision surgery.High impedance and device disablement were confirmed prior to replacement.During the replacement surgery, it was reported that the electrodes were torqued and pulled on the vagus nerve, but the electrodes remained attached to the nerve.One tie-down was found.The surgeon reportedly did not see any gross lead fractures.The generator and lead were replaced which resolved the high impedance.The products were received, but analysis has not been approved to date.No further relevant information has been received to date.

Event Description

Product analysis was completed on the generator.The generator was able to be interrogated and system diagnostics were performed using different load resistors.Results were normal.The data from the generator was also reviewed.The measured battery voltage was slightly lower than expected based on the expected charge consumed because of the excess battery drain from high impedance.The data also showed when the 599.2% change in measured lead impedance from normal impedance to high impedance occurred.No other relevant information has been provided to date.

Event Description

Product analysis was completed on the lead.The lead was returned in four parts including one loose tie-down.The electrodes were not returned and could not be evaluated.During the visual analysis of one of the returned portions, the coil appeared to be broken near the electrode bifurcation.Scanning electron microscopy was performed and identified the area on three of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type with pitting on two of these broken coil strands.The area on the remaining broken coil strand was identified as having evidence of a stress induced fracture with mechanical damage and pitting.Pitting was observed on the coil surface.Abraded openings were also seen on the outer tubing and allowed fluid entry into the outer tubing.No other visual anomalies were seen besides the typical wear normal found after an explant procedure.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 and other discontinuities were found.No relevant information has been obtained 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: 6712687
• MDR Text Key: 80011131
• Report Number: 1644487-2017-04143
• 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,Followup
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/14/2008
• Device Model Number: 302-20
• Device Lot Number: 1176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2005
• 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: 15 YR