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

Model Number 302

Device Problems Corroded (1131); Fluid/Blood Leak (1250); Fracture (1260); Low impedance (2285)

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

Event Date 01/31/2016

Event Type  malfunction  

Event Description

It was reported that the physician performed a diagnostic test during a visit and observed a low impedance warning.Chest x-rays were reviewed by the physician and a lead fracture was observed.These images have not been reviewed by the manufacturer to date.It is unknown if the patient sustained an injury which could have caused the lead fracture.The device was programmed off and the patient was referred for surgery.No surgical interventions are known to have occurred to date.

Event Description

It was reported that the patient underwent lead and generator replacement surgery.The explanted products have not been received to date.

Event Description

The explanted lead and generator were received.Both are currently pending analysis.

Event Description

Analysis was completed on the returned generator and lead.During testing the generator performed to functional specification and no anomalies were observed.The internal data of the generator was reviewed and confirmed that a low impedance had occurred while implanted.The lead was received in 5 segments which included the lead pin and electrodes.There were set screw marks on the pin which indicated that there was good contact between the lead and generator at one time.Abrading openings were found in the inner and outer tubing in various locations in the lead.Scanning electron microscopy was used to evaluate the lead and found broken coil strands with evidence that the fracture was stress induced from fatigue and rotational forces.There was evidence of pitting on one coil strand which indicates that the fracture was present while stimulation was occurring.Additionally with the abraded insulation, it was found that a short condition was occurring between the coils.Analysis of the lead confirmed the short circuit condition which caused the low impedance.

• 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: 6852981
• MDR Text Key: 85448119
• Report Number: 1644487-2017-04430
• 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: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2009
• Device Model Number: 302
• Device Lot Number: 1538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/15/2017
• Initial Date FDA Received: 09/08/2017
• Supplement Dates Manufacturer Received: 09/26/2017; 10/11/2017; 11/07/2017
• Supplement Dates FDA Received: 10/11/2017; 10/31/2017; 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2006
• 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: 11 YR