MAUDE Adverse Event Report: CYBERONICS, INC. BIPOL LEAD MODEL 300

Model Number 300-20

Device Problem High impedance (1291)

Patient Problem Pain (1994)

Event Date 08/28/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient was experiencing painful stimulation.The patient¿s device was tested and system diagnostic results revealed high impedance (dc dc ¿ 6).X-rays were taken and were reported by the physician to be unremarkable.No known surgical interventions have occurred to date.

Event Description

Product analysis for the generator was completed and approved on (b)(4) 2015.In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment.The output exhibited output variations on chart.This condition was due to an intermittent connection on the alligator clip, used to establish an electrical connection to the generator.The pulse generator was monitored again for more than 24-hrs and results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.The reported ¿detachment of components(s)/header¿ allegation, most likely occurred during or after the explant process.This is based on the location of the tool marks observed on the pulse generator case and header.In addition, the generator as received photo shows no evidence of bodily fluid remnants in the case/header area.Therefore, this observation/finding is not considered a device failure, but instead the result of extensive manipulation of the product during or after the explant process.The generator performed according to functional specifications.Other than the intermittent connection issue that is not related to the generator and the header anomaly (visual analysis), there were no performance or any other type of adverse conditions found with the pulse generator.

Event Description

Product analysis for the generator that was completed on 04/16/2015 concluded that the generator detachment of components was most likely attributed to explant related events.Therefore the possibility of a lead break cannot be ruled out.The patient's lead has not been explanted to date.

Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative

Device failure occurred, but did not cause or contribute to death or serious injury.

Manufacturer Narrative

Corrected data: changed suspect device to lead.

Event Description

It was reported that the patient underwent generator replacement on (b)(6) 2015.It was stated that the generator was in two pieces as the header was detached from the generator.The lead was not replaced.When the new generator was attached to the old lead impedance values were good at 2825 ohms.The generator was returned for analysis on 03/19/2015.Analysis is currently underway but has not been completed to date.

• Brand Name: BIPOL LEAD MODEL 300
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4115750
• MDR Text Key: 4937874
• Report Number: 1644487-2014-02461
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/28/2014

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: 06/30/2002
• Device Model Number: 300-20
• Device Lot Number: 39845C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/25/2015
• Initial Date FDA Received: 09/24/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/06/2015; 04/29/2015; 07/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2000
• 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: 30 YR