MAUDE Adverse Event Report: CYBERONICS LEAD MODEL 302

Model Number 302-20

Device Problem Low impedance (2285)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Seizures (2063); Therapeutic Response, Decreased (2271)

Event Date 04/14/2015

Event Type  malfunction  

Event Description

It was reported that the vns patient had presented with increased seizures and painful stimulation.System diagnostics were run on the vns system on (b)(6) 2015 and they returned a dcdc code 0.Normal mode diagnostics were run on the vns system on (b)(6) 2015 and they returned a dcdc code 0.The pulse generator was disabled.Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.A battery life estimation for the implanted generator returned 0 years expected until near end of service.Programming history data was reviewed though (b)(6) 2012.The device was last programmed to a 16% duty cycle.The last parameters recorded were 2 ma/30hz/500usec/30sec/3min, magnet mode 2.25ma/60sec/500usec.Diagnostic history data revealed that system diagnostics recorded on (b)(6) 2012 returned a lead impedance result within normal ranges.Normal mode diagnostics were run on (b)(6)2012 recorded on (b)(6) 2012 returned a lead impedance result within normal ranges.Magnet mode diagnostics recorded on (b)(6) 2012 returned a lead impedance result within normal ranges.Further information was received indicating that the patient had presented pain at the generator implant site.It was also indicated that the patient had undergone a generator replacement the previous year.X-rays were taken and reviewed at the healthcare facility.It was reported that review by the healthcare professional had not found any lead break or disconnection of the lead.Review of the x-showed that the generator appears in the upper left chest in a normal placement.The filter feed-through wires appeared to be intact.The lead connector pin seemed to be fully inserted into the generator connector block.The electrodes appeared normally placed on the vagus nerve.It is difficult to assess if the strain relief bend and loop were used.The tie downs were used but it is unclear, if those were used as indicated in the labeling, due to the picture quality.Part of the lead was behind the generator.No sharp angles or lead breaks were visible on the assessed lead parts.Based on the x-rays, the cause of the reported low impedance remains unknown.Further information was received stating that the seizure frequency was above the pre-vns seizure rate, with complex partial and tonic-clonic seizures.No manipulation of the vns system was suspected.The patient had undergone battery replacement in (b)(6) 2014.On (b)(6) 2015 system diagnostics returned a dcdc code 0, low impedance result.The patient presented mild painful stimulation with a strange sensation near the generator.No known surgical interventions have occurred to date.

Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device.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.X-rays reviewed by manufacturer, no gross lead discontinuities visualized.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; 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: 4761632
• MDR Text Key: 5949001
• Report Number: 1644487-2015-04650
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2010
• Device Model Number: 302-20
• Device Lot Number: 200403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2007
• 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: 34 YR