MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 302

Model Number 302-20

Device Problem High impedance (1291)

Patient Problems Fall (1848); Seizures (2063)

Event Date 04/01/2013

Event Type  malfunction  

Event Description

The neurologist reported that the high impedance was observed at the patient's first visit with the physician and that device diagnostics with the previous physician in 2011 were within normal limits.The device was programmed off.The neurologist reported that x-rays were taken and that the plan was to leave the device programmed off and observe the patient for four to eight weeks.No surgical intervention have been performed to date.

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 neurologist reviewed the patient¿s clinic notes and stated that high impedance was observed during an office visit in (b)(6) 2013.The patient¿s device was not programmed off at that time.The neurologist reported that the patient continues to have seizures and experienced a fall the previous week.The patient was reported to be non-verbal but active, so it is unclear what may have caused or contributed to the high impedance.No known interventions have occurred to date.

Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records confirmed there were no unresolved non conformances found with the lead prior to distribution.

• 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: 3761245
• MDR Text Key: 4453349
• Report Number: 1644487-2014-01061
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2008
• Device Model Number: 302-20
• Device Lot Number: 954
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/27/2014
• Initial Date FDA Received: 04/21/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/22/2014; 09/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2005
• 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: 35 YR