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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problem Neck Pain (2433)

Event Date 02/16/2016

Event Type  malfunction  

Event Description

It was reported that the patient experienced pain in the neck area.Device diagnostics resulted in high impedance (dc dc code 7).The patient refused to have the device programmed off.The patient was referred for surgery.No known surgical interventions have been performed to date.

Event Description

Clinic notes dated (b)(6) 2016 note that the patient is losing her voice more and cannot eat solid foods much.The patient underwent generator and lead replacement on (b)(6) 2016.The explanted devices have not been received for analysis to date.

Event Description

It was reported that the explanted devices were discarded; therefore, no product analysis can be performed.

Manufacturer Narrative

Date of event: this information was inadvertently reported incorrectly on initial mfr.Report.

• 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: 5495368
• MDR Text Key: 40433754
• Report Number: 1644487-2016-00531
• 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,Followup
• Report Date: 02/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2016
• Is this an Adverse Event Report?: Yes
• 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: 200431
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2007
• 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: 29 YR