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

Model Number 302-20

Device Problem Malposition of Device (2616)

Patient Problems Erythema (1840); Swelling (2091)

Event Date 11/01/2014

Event Type  Injury  

Event Description

It was reported that the patient was seen by an ent and it was found that one of the leads is lying on the patient¿s vocal cord and causing redness and swelling.The patient was referred for a ct scan.It was reported that the physician would like the patient to undergo vns replacement.No known surgical interventions have been performed to date.No additional relevant information has been received to date.

Event Description

The explanted generator was returned on (b)(6) 2015.Analysis is underway but has not been completed.

Event Description

The generator reaching end of service was determined to be the result of normal battery depletion.The depletion was an expected event as determined by blc and battery voltage measurement.There were no performance or any other type of adverse conditions found with the pulse generator.

Manufacturer Narrative

Manufacturer Narrative

Device available for evaluation?, corrected data: no.The suspect device was not available for evaluation.Supplemental #2 report incorrectly reported that the device was for evaluation.Device evaluated by mfr? corrected data: not returned to mfr.The suspect device was not returned.Supplemental #2 report incorrectly reported that the device was returned.

Event Description

Additional information was received that the patient underwent generator replacement on (b)(6) 2014.Attempts for product return were made but the explanted generator has not been received to date.

• Brand Name: LEAD MODEL 302
• 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: 4294419
• MDR Text Key: 5054220
• Report Number: 1644487-2014-03196
• Device Sequence Number: 1
• Product Code: MUZ
• 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,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2008
• Device Model Number: 302-20
• Device Lot Number: 016111
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/16/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/13/2015
• Initial Date FDA Received: 12/03/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/27/2015; 04/09/2015; 05/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2006
• 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): Other; Required Intervention
• Patient Age: 58 YR