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

Model Number 302-20

Device Problem Insufficient Information (3190)

Patient Problem Abscess (1690)

Event Date 08/21/2014

Event Type  Injury  

Event Description

It was reported that the patient underwent an incision and drainage of a left scapular abcess and complete removal of the vns system.Both lead and generator were explanted.The explanted devices were returned for analysis.Analysis is underway, but has not been completed to date.Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description

Analysis of the lead was completed on 09/22/2014.Multiple breaks were confirmed in the negative coil of the returned lead portions.Mfr.Report # 1644487-2014-02711 will house the lead analysis.Analysis of the generator was completed on 09/25/2014.The pulse generator module performed according to functional specifications.There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.

Event Description

Based on the information available to date, the reported left scapular abscess appears to be the result of lead dissolution: when a lead fracture occurs and a small length of the lead is exposed to extracellular fluid, the broken end of the lead acts as the electrode.The current delivered by the pulse generator is conducted through the very small surface area of the fractured lead.The result of this event is the pitting at the broken end of the coil wire.Adverse events associated with this event can include infection-like symptoms including inflammation, pain, or edema of abscess.The adverse events reported here appear to be the result of the lead malfunction reported in mfr report #1644487-2014-02711.

Manufacturer Narrative

Brand name, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead.Type of device, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead.Model #, serial #, lot #, expiration date, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead.Device manufacture date, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead.

• 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: 4103311
• MDR Text Key: 4836291
• Report Number: 1644487-2014-02414
• 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: User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2009
• Device Model Number: 302-20
• Device Lot Number: 1598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2006
• 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: 12 YR