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

Model Number 304-20

Device Problem High impedance (1291)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2014

Event Type  malfunction  

Event Description

It was reported that high lead impedance was observed for the vns patient¿s device.The patient was subsequently programmed off.Patient manipulation or trauma is not believed to have caused or contributed to the high impedance.The patient was reported to be doing well.Review of the available programming and diagnostic history showed the last normal diagnostic results were from (b)(6) 2011.No known interventions have occurred to date.Attempts for additional relevant information were made but have been unsuccessful to date.

Event Description

Additional information was received that the patient has been having 4-5 drop attacks per day.Although surgery is likely, it has not occurred to date.

Event Description

On (b)(4) 2014, it was reported that the patient had been having quite a few seizures.

Event Description

It was reported that the patient underwent full revision surgery.The explanted lead and generator have not been received to date.Device diagnostics with the new lead and generator were within normal limits.

Manufacturer Narrative

Device manufacturing records and available programming and diagnostic history were reviewed.Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description

It was reported that the explanted lead and generator were discarded.

• 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: 3770336
• MDR Text Key: 4436547
• Report Number: 1644487-2014-01099
• 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: Consumer,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/01/2014

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2014
• Device Model Number: 304-20
• Device Lot Number: 201584
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 06/25/2015
• Initial Date FDA Received: 04/24/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/11/2014; 01/13/2015; 07/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2010
• 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: 22 YR