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

Model Number 302-20

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2013

Event Type  malfunction  

Event Description

It was reported that the patient was having the vns generator and lead explanted due to the generator being at end of service since 2014 and the patient being a non-responder when the generator was on.The explanted generator and lead were returned for product analysis.Product analysis on the generator found that it was at end of service and could not be communicated with.The battery's voltage was 0.6v, the generator will no longer communicate after the battery reaches 1.8v.Product analysis on the lead identified fractures of the quadfilar coils and abraded openings of the outer and inner tubings.It was also noted that the quadfilar coil had signs of pitting which appeared to be the result of stimulation being provided after the fracture had occurred.Review of the internal programming history database contained data up until (b)(6) 2012 where diagnostic results were within normal limits.Therefore it is known that the lead fracture occurred after (b)(6) 2012.Due to the pitting that was observed it is likely that the fracture occurred prior to the generator's end of service condition.

Manufacturer Narrative

Corrected data: describe event or problem; this information was inadvertently left off on mfg.Report #0.

Event Description

Product analysis found fluid leaks in the lead.

• 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: 5791147
• MDR Text Key: 50178169
• Report Number: 1644487-2016-01578
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2010
• Device Model Number: 302-20
• Device Lot Number: 200471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 08/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2007
• 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 Age: 14 YR