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

Model Number 302-20

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Paresis (1998)

Event Date 11/04/2014

Event Type  malfunction  

Event Description

High impedance with dcdc - 5 was observed for patient.The generator was turned to 0ma due to an ongoing issue of gastro-paresis caused by the vns (reported in manufacturer report # 1644487-2015-04996).The generator was turned back to therapeutic settings on (b)(6) 2015 with dcdc = 6 in system mode and at dcdc = 5 in normal mode diagnostics.A cervical spine x-ray has been taken and no obvious lead continuity issues were noted by the neurologist.No adverse events other than gastro-paresis were reported.The patient has not reported a fall or trauma to the site.The patient also has a portacast, a medication port, installed in their chest.It was implanted post vns within 4 inches of the vns therapy system but contains no electronic components.It has been present for "a while" and has not interfered with the vns in any way.

Event Description

Patient's x-rays were received and reviewed.There was no image of the generator received.There are no obvious lead breaks identified in the visible lead portion.The electrodes appear to be inline on the patient¿s nerve.There was a spiral appearance of the lead after the tie downs in the lead body that does not continue through the length of the lead.The cause of the spiral appearance in the small potion of the lead is likely related to patient manipulation.

Manufacturer Narrative

Device manufacturing records and available programming and diagnostic history were reviewed.Device failure is suspected, but did not cause or contribute to a death.

Event Description

Patient underwent full revision of the lead and generator on (b)(6) 2015.The explanted products have not been received to date and may be returned by the explant facility only if the patient allows them to.

• 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: 4870962
• MDR Text Key: 6258523
• Report Number: 1644487-2015-05023
• Device Sequence Number: 1
• Product Code: MUZ
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/03/2015

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: 06/30/2008
• Device Model Number: 302-20
• Device Lot Number: 1142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 06/26/2015
• Initial Date FDA Received: 06/26/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2005
• 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: 47 YR