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

Model Number 302-20

Device Problems High impedance (1291); Improper or Incorrect Procedure or Method (2017)

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

Event Date 08/13/2015

Event Type  malfunction  

Event Description

It was reported that high lead impedance was found on patient vns system upon system diagnostic test.Information was received that the generator was switched off and that x-rays were taken.X-rays were provided to the manufacturer for further review.The generator appears in the upper left chest in a normal placement.The filter feed-through wires seemed to be intact.The lead connector pin appeared to be fully inserted into the generator connector block.The electrodes appeared to be placed in normal arrangement.A strain-relief bend and a strain-relief loop were found for the implant of the lead.The strain-relief bend and loop were not used/made as indicated by the labeling.No tie-down was placed to secure the implanted lead.Part of the lead was behind the generator.No acute angles or clear breaks were found in the parts of the lead that were visible and could be assessed.No known surgical interventions have occurred to date.Review of manufacturing records confirmed all tests passed for the concerned lead prior to distribution.

Event Description

Additional information received that patient's parent decided to switch off the generator.No known surgical interventions have occurred 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: 6029490
• MDR Text Key: 57573499
• Report Number: 1644487-2016-02302
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/05/2017
• Device Model Number: 302-20
• Device Lot Number: 202395
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2013
• 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: 21 YR