MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 303

Model Number 303-20

Device Problem High impedance (1291)

Patient Problem Discomfort (2330)

Event Date 12/23/2015

Event Type  malfunction  

Event Description

It was reported that a patient, who was recently implanted with vns, experienced discomfort when the device was initially programmed on.Diagnostics showed that high impedance was present.The physician programmed the patient's generator off and ordered x-rays.The physician's office evaluated the chest x-rays that were taken on (b)(6) 2015, and they did not see anything that looked wrong.The x-rays were not available for livanova to evaluate.The patient had lead revision surgery on (b)(6) 2016.The surgeon did not test the lead impedance during surgery.He did not test the connection of the existing lead to the generator prior to replacing it.Therefore, it cannot be determined if there was incomplete lead pin insertion.The explanted lead is expected for return, but it has not been received to date.

Manufacturer Narrative

Udi of suspect device: (b)(4).Brand name, corrected date: initial report inadvertently reported the incorrect brand name of the suspect device.Model #, corrected data: initial report inadvertently reported the incorrect model of the suspect device.

Event Description

The patient felt pain in the left neck when her vns was turned on.The explanted lead was received on 02/02/2016.Analysis has not been completed to date.

Event Description

Analysis was completed on 03/01/2016.The entire lead was evaluated.Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.Setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the lead pin existed at least once.The high impedance was most likely related to a lead pin insertion issue since the lead did not have any anomalies that would have caused the high impedance.Since the pain the patient felt was in the neck area, it would not have been related to the high impedance, which only would have caused painful stimulation at the generator site.

• Brand Name: LEAD MODEL 303
• 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: 5371512
• MDR Text Key: 36474383
• Report Number: 1644487-2016-00122
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/06/2015
• Device Model Number: 303-20
• Device Lot Number: 203371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2015
• 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: 52 YR