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

Model Number 302-20

Device Problems Break (1069); High impedance (1291)

Patient Problem Seizures (2063)

Event Date 07/01/2015

Event Type  malfunction  

Manufacturer Narrative

Event Description

It was reported on (b)(6) 2015 that this patient was seen on (b)(6) 2015 and it was reported that a lead is broken and the patient needs to undergo replacement.Further follow-up showed that the patient was seen with increase in seizures and x-rays indicated a lead break and high lead impedance was seen.It was noted that the patient is rather clumsy and unstable and they are quite sure that he fell or injured himself.He has recently had a huge increase in nocturnal seizures.Clinic notes received on 08/03/2015 dated (b)(6) 2015 state that the patient had his device replaced last summer and he did well with no further seizure activity until approximately 3 weeks ago.His mother is not sure what to attribute the increase to.The patient underwent lead replacement on (b)(6) 2015.A new generator was not implanted as the current generator has only been implanted since (b)(6) "1014" and battery is nearly full.The explanted generator has not been received for analysis to date.

Event Description

The suspect device (lead) was received into analysis on 10/13/2015.Analysis his currently underway but has not been completed to date.

Event Description

Product analysis for the lead was completed and approved on 11/17/2015.A break was identified in the returned lead portions.Scanning electron microscopy images of the positive coil show that pitting (corrosion) have occurred at the broken ends.One strand of the coil end (1st lead portion) and two strands of the positive coil at the mating end show appearance suggesting that a stress-induced fracture has occurred on the coil.The negative coil shows that pitting or electro-etching conditions have occurred at the broken end.Due to mechanical distortion (smoothed surfaces), surface contamination and metal dissolution the fracture mechanism of other strands of the broken coils cannot be ascertained.There were abraded openings of only the inner tubing in an area by the helicals.There were also abraded openings of only the outer tubing in the middle / 'body' section of the lead.The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing.

• 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: 5029003
• MDR Text Key: 24812757
• Report Number: 1644487-2015-05613
• 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: Health Professional
• Type of Report: Followup,Followup
• Report Date: 07/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2011
• Device Model Number: 302-20
• Device Lot Number: 200937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2008
• 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 Age: 11 YR