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

Model Number 302-20

Device Problems Corroded (1131); Fracture (1260); Mechanical Problem (1384)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994)

Event Date 05/17/2017

Event Type  malfunction  

Event Description

It was reported that the patient had high lead impedance and erratic stimulation.It was later reported that the patient was being shocked and the shock felt more intense.No known relevant surgical intervention has occurred to date.No further relevant information has been received to date.

Event Description

The patient underwent surgery to replace their generator prophylactically and their lead due to high impedance.No further relevant information has been received to date.The suspect product has not been returned to date.

Event Description

The explanted generator and lead were received.Product analysis on the devices has not been completed to date.No further relevant information has been received to date.

Event Description

Product analysis was completed on the returned generator.The generator was monitored for 24 hours in a simulated body temperature environment.The generator provided the intended output current for the entirety of the monitoring period.A comprehensive electrical evaluation showed that the device performed according to functional specifications.No anomalies were identified.Product analysis was completed on the returned lead.The lead body was returned in two pieces.The electrodes were not returned and so could not be evaluated.Product analysis verified the presence of a lead fracture in two places.At these two locations, there were abraded openings in the inner and outer tubing.Scanning electron microscopy showed pitting occurred at the break locations.Due to the pitting, the fracture method could not be determined.No other anomalies were identified in the returned lead portions.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: 6633172
• MDR Text Key: 77305030
• Report Number: 1644487-2017-03959
• 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: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2006
• Device Model Number: 302-20
• Device Lot Number: 011400
• 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: 10/16/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/02/2004
• 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: 55 YR