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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problem Seizures (2063)

Event Date 09/02/2014

Event Type  malfunction  

Event Description

It was reported that the patient moved states and has not been seen by a physician in 8 months.The patient reported that he feels a sensation in his chest area and is experiencing an increase in seizures.The patient was seen by a physician and device diagnostics resulted in high impedance (dc dc code - 7).The patient was referred to surgeon.The patient underwent generator and lead replacement (including electrodes).The explanted lead and generator were received for analysis.Analysis is underway, but has not been completed to date.

Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death.

Event Description

Analysis of the returned generator and lead was completed.There were no anomalies found with the pulse generator.The generator performed according to functional specifications.Analysis of the returned lead portion confirmed discontinuity of negative quadfilar coil in the electrode region.Some of the broken coil strands was identified as having pitting.Pitting was observed on the coil surface.It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.The abraded opening found on the outer silicone tubing and the cut ends made during the explant process most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing.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.

Manufacturer Narrative

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

• 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: 4210932
• MDR Text Key: 4979744
• Report Number: 1644487-2014-02882
• 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: Health Professional,Company Representative
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 10/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2011
• Device Model Number: 302-20
• Device Lot Number: 2004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2014
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 11/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2008
• 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: 29 YR