MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

Model Number 304-20

Device Problem Fracture (1260)

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

Event Date 10/14/2015

Event Type  malfunction  

Event Description

It was reported that the patient had a fractured lead but underwent replacement on (b)(6)2015.It is unknown what specific devices were replaced (generator and/or lead).It is also currently unknown how the lead was determined to be fractured.No additional relevant information has been obtained to date.

Event Description

Additional information was received which clarified that both the generator and lead were explanted on (b)(6) 2015.No additional relevant information has been obtained to date.

Event Description

The explanted generator and lead were received on 01/29/2016.The reported "fracture of lead" allegation was not verified.Scanning electron microscopy images of the connector pin verified that pitting or electro-etching conditions have occurred on the connector pin.An energy dispersive spectrometry (eds) analysis performed on a sample of the reddish-brown deposits observed on the pin showed the presence of some elements present in stainless steel 316.The higher percentage of iron in this sample suggests oxidation may have occurred.An abraded opening of the outer tubing was observed in one location.Since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary could not be made on that portion of the lead.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.The reported allegation of "high impedance" was not duplicated in the pa lab.Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery, 3.036 volts, shows an ifi=no condition.In addition, signs of discoloration were also observed on the pulse generator case, which is consistent with the adhered remnants of dried body fluids following an explant process.No other surface abnormalities (such as sharp edges, header delamination, open pockets, decomposition, corrosion or voids) were noted on this device.Observations under pa lab bench microscope revealed pitting on the negative connector block and setscrew.Other than the noted visual anomalies, there were no performance or any other type of adverse conditions found with the pulse generator.

• Brand Name: LEAD MODEL 304
• 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: 5206930
• MDR Text Key: 30858681
• Report Number: 1644487-2015-06358
• 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: Initial,Followup,Followup
• Report Date: 10/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2015
• Device Model Number: 304-20
• Device Lot Number: 201975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2011
• 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