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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problem Seizures (2063)

Event Date 03/26/2014

Event Type  malfunction  

Event Description

Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014.The explanting facility discarded the explanted devices; therefore, no analysis can be performed.

Event Description

Additional information was received stating that the patient¿s increase in seizure was related to a possible device malfunction and high impedance.The increase in seizures was above pre-vns baseline levels and all of the patient¿s seizure types had increased.X-rays were taken and were reported by the physician to be unremarkable.

Event Description

It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and diagnostic results revealed high lead impedance (dc dc ¿ 7).The patient¿s device was subsequently programmed off.No patient trauma was reported.The patient was seizure free for over a year until recently when he began having several seizures per month.Clinic notes were received indicating that the no patient or device issues were noted during the patient¿s previous office visit on (b)(6) 2014.The notes state that x-rays were taken and were reported by the physician to be unremarkable.Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012.No known interventions have occurred to date.

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.

• 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: 3763225
• MDR Text Key: 4406373
• Report Number: 1644487-2014-01063
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2014

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: 12/31/2010
• Device Model Number: 302-20
• Device Lot Number: 200673
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/16/2014
• Initial Date FDA Received: 04/22/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/15/2014; 05/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2007
• 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: 19 YR