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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problem Seizures (2063)

Event Date 01/04/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient was scheduled for lead replacement surgery.Additional information was received stating that diagnostic results revealed high lead impedance and that the patient was experiencing an increase in seizures for several months.The patient¿s device was programmed off on (b)(6) 2014.Surgery has not occurred to date.Review of the available programming and diagnostic history only found diagnostic results from the day of implant which revealed normal device function at that time.

Event Description

The patient's mother reported that she is not going to proceed with surgery.The device has been programmed off for a couple of months and the patient is doing fine with her seizures.The patient's mother reported that the seizures are below pre-vns baseline.

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.

Event Description

The patient had revision surgery for the lead and generator due to high impedance.The products were received and analysis is underway, but has not been completed to-date.

Event Description

Analysis was completed on the returned lead and the report of lead fracture was confirmed.The lead was returned intact and a discontinuity was identified.Scanning electron microscopy identified three of the broken coil strands and surface had pitting.The remaining broken coil strand was mechanically damaged.The mating end of the electrode and one of the broken coil strands had evidence of a fatigue stress induced fracture with mechanical damage, fine pitting and a rotational stress induced fracture.The area on the remaining broken coil strands had evidence of a stress induced fracture with mechanical damage.With the exception of the observed discontinuity, no other anomalies were noted.Analysis for the generator was completed on (b)(4) 2015.The device was automatically disabled (pulsedisabled) and end-of-service warnings were set.The pulsedisabled byte would not reset.The measured battery results, confirmed an end-of-service condition.Review of the generator data showed increased impedance, from 2912 ohms to 13,088 ohms, and the date of change detection was (b)(6) 2014.The electrical test results showed that the pulse generator module performed according to functional specifications.

• 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: 3717903
• MDR Text Key: 4251898
• Report Number: 1644487-2014-00843
• 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
• Report Date: 03/06/2014

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: 12/31/2011
• Device Model Number: 302-20
• Device Lot Number: 2239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/16/2014
• Initial Date FDA Received: 04/01/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2008
• 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: 16 YR