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

Model Number 302-20

Device Problems High impedance (1291); Unexpected Therapeutic Results (1631)

Patient Problems Seizures (2063); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 06/01/2014

Event Type  malfunction  

Event Description

It was reported that the patient underwent lead replacement on (b)(6) 2015.Device diagnostics on the surgery date returned impedance within normal ranges (1440 ohms).Further information was received indicating that the outcome for the patient was satisfactory and that new device diagnostics returned impedance within normal ranges (2959 ohms).The explanted lead has not been returned to the manufacturer to date.

Event Description

The returned lead was analyzed.Visual analysis of the returned portion found that the positive connector ring quadfilar coil appeared to be broken approximately 1.5mm from the electrode bifurcation.Scanning electron microscopy identified that the area was mechanically damaged, which prevented identification of the coil fracture type.Pitting was observed on the coil surface, which evidences that stimulation was present for a certain period of time.Low magnification scanning electron microscopy analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution and what appeared to be white deposits were observed in various locations.With the exception of the observed discontinuity the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were noted.Continuity checks of the returned lead portion were performed, during the visual analysis, and no other discontinuities were identified.

Event Description

It was reported that the lead became twisted and coiled during explant.The lead was received for analysis.Analysis is underway, but has not been completed to date.

Manufacturer Narrative

Device failure occurred, but did not cause or contribute to patient death.

Event Description

It was reported that device diagnostics resulted in high impedance (>10,000 ohms).X-rays were taken and sent to manufacturer for review.It was reported that the patient's increase in seizures was being managed by optimisation in medication.Radiology report indicated that no break in the lead was seen.Review of x-rays by manufacturer did not identify any suspected lead discontinuity.The lead pin appeared to be fully inserted into the generator header.The cause of the high impedance was unable to be determined based on the x-ray images received.It was reported that the device was programmed off after observing the high impedance.There was no patient manipulation or trauma that is believed to have caused or contributed to the high impedance.No known surgical intervention has occurred to date.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.Device failure is suspected, but did not cause or contribute to a death or serious injury.

• 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: 4193982
• MDR Text Key: 5652379
• Report Number: 1644487-2014-02785
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup,Followup,Followup
• Report Date: 09/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2008
• Device Model Number: 302-20
• Device Lot Number: 11265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2005
• 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: 24 YR