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

Model Number 302-20

Device Problem Fracture (1260)

Patient Problem Dysphagia/ Odynophagia (1815)

Event Date 04/16/2018

Event Type  malfunction  

Event Description

It was reported by a provider that a vns patient has high lead impedance.The provider stated she had last checked the generator in (b)(6) 2017 and no issues were seen.The family denies any kind of traumatic event that may have damaged the system.They deny that the patient fidgets with the device or picks at it.They reported that the patient recently had gall bladder surgery and the family was worried that the device may not have been functioning correctly after that and wanted to follow up and have the device checked.Clinic notes were received indicating the patient has more clearing of her throat and diagnostics showed high impedance.No known surgery has occurred to-date.Additional relevant information has not been received to-date.

Event Description

Surgery occurred and both the lead and generator were replaced and the new system indicated ok impedance.It is noted that the hospital discards the explanted devices and no device will be returned for analysis.No further relevant information has been received 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: 7507299
• MDR Text Key: 108148946
• Report Number: 1644487-2018-00766
• 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
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2006
• Device Model Number: 302-20
• Device Lot Number: 10789
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2004
• 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: 25 YR