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

Model Number 302-20

Device Problems Fracture (1260); High impedance (1291); Material Protrusion/Extrusion (2979); Scratched Material (3020)

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

Event Date 04/19/2012

Event Type  malfunction  

Event Description

It was reported that the was to undergo generator replacement surgery.In pre-op diagnostics were run on the generator and found high impedance.During surgery it was noted that the lead was visibly fractured.The lead was then explanted and returned for product analysis.The product analysis lab found that the lead had abrasions of the inner and outer tubing of the lead.The lead coil was protruding out of the abraded tubing and the lab confirmed a lead discontinuity.

Event Description

It was reported that the explanted generator would be returned for analysis due to a failed vns system.The generator was returned and underwent product analysis.Analysis found that during final electrical testing the generator performed to functional specifications.During review of the in house programming history database, it was observed that the high impedance was first observed on b)(6) 2012.It was identified that this high impedance was previously reported in the high impedance summary report mfg report 1644487-2014-00290.This mfr.Report will house any further information regarding the high 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: 5597078
• MDR Text Key: 44207021
• Report Number: 1644487-2016-00856
• 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
• Report Date: 03/24/2016

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: 01/31/2011
• Device Model Number: 302-20
• Device Lot Number: 200695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/24/2016
• Initial Date FDA Received: 04/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2008
• 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 Age: 16 YR