MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

Model Number 304-20

Device Problems Corroded (1131); Fracture (1260); Mechanical Problem (1384); Under-Sensing (1661); Low impedance (2285)

Patient Problem No Code Available (3191)

Event Date 06/05/2017

Event Type  malfunction  

Event Description

It was reported that the generator was not detecting heart rate.The internal data of the generator was reviewed and it was determined that low impedance had been detected on the device in the past as well as a large drop in impedance.Low impedance may interfere with heartbeat detection.The generator was later able to detect heart rate when the sensitivity was set to its least sensitive detection setting (sda sensitivity - 1).However, approximately four months later, the generator continued to have difficulty detecting heart rate.Low impedance was detected intermittently through system diagnostics.The patient reported that approximately a year ago she had felt a 'movement' in her neck, where the lead connected to the nerve and when she moved her head back, the movement reversed and 'went back.' the patient said that she still felt normal and magnet mode stimulation.No known relevant surgical intervention has occurred to date.No further relevant information has been received to date.

Event Description

It was reported that the patient's lead and generator had been replaced due to low impedance.During explant a kink in the lead was observed that had caused the tubing to rupture.Reportedly there was nothing unusual about the placement of the lead on the nerve.The explanted lead and generator were received, but product analysis on the devices have not been completed to date.No further relevant information has been received to date.

Manufacturer Narrative

(b)(4).

Event Description

Product analysis was completed on the returned generator.The generator was able to sense heart-rate normally.No anomalies were identified with the generator.Product analysis was completed on the returned lead.The lead was received in two pieces and the electrodes were not received.Two (2) abraded openings in just outer tubing were identified.One abraded opening in the inner and outer tubing was observed.At this opening, a lead break in the positive coil was found and pitting conditions were observed at the location.Dried body fluids were identified in the inner and the outer silicone tubing.No obvious point of entrance was noted other than the identified tubing openings and the cut ends of the returned lead portion.No other anomalies were identified in the returned lead portions.No further relevant information has been received to date.

• Brand Name: LEAD MODEL 304
• 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: 7011776
• MDR Text Key: 92315626
• Report Number: 1644487-2017-04745
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/29/2019
• Device Model Number: 304-20
• Device Lot Number: 203511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 19 YR