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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problem No Code Available (3191)

Event Date 03/21/2016

Event Type  malfunction  

Event Description

High impedance (>10,000 ohms) was observed for patient's generator during a routine follow up appointment on (b)(6) 2016.Patient's device was checked on (b)(6) 2016 prior to the visit and diagnostics were within normal limits at that time.Patient did not fall.Patient was referred for x-rays and possible surgical consult.No known surgical intervention has occurred to date.

Event Description

Additional information was received that the patient's generator was disabled on (b)(6) 2016 upon seeing the high impedance message.Patient's x-rays were provided and reviewed.The generator appears normally placed on the left chest.The connector pin appears to be fully inserted inside the connector block.There does not appear to be any damage to the generator.The lead is seen routing up to the neck.The electrodes appear to be aligned at the nerve but placement is difficult to visualize.Based on the images seen, the lead appears intact and there are no gross discontinuities on the lead or at the generator that could be visualized but a microfracture cannot be ruled out.As an incomplete pin insertion was ruled out as the cause of high impedance, fracture within the lead is suspected.No known surgical intervention has occurred to date.

Event Description

Patient was seen by a surgeon for her neck issues and underwent explant surgery on (b)(6) 2016.The explanted device was not received to date and the explant hospital was reported to discard all implants after pathology.

• 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: 5760034
• MDR Text Key: 49159026
• Report Number: 1644487-2016-01468
• 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
• Report Date: 06/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2010
• Device Model Number: 302-20
• Device Lot Number: 200401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2006
• 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: 49 YR