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

Model Number 302-20

Device Problems Corroded (1131); Fracture (1260)

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

Event Date 01/10/2018

Event Type  malfunction  

Event Description

It was reported that high impedance was seen on the patient's device, and the battery is not at eos.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

The patient¿s full revision surgery has been completed.The products have not been received by the manufacturer to date.No other relevant information has been received to date.

Event Description

The lead and generator were received by the manufacturer for product analysis.The lead underwent product analysis where the negative electrode quadfilar coil appeared to be broken near the electrode bifurcation.Scanning electron microscopy was performed and identified evidence of a stress induced fracture.Extensive 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 most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing.With the exception of the observed abraded opening and 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.Analysis of the generator is underway but has not been completed to date.No other relevant information has been received to date.

Event Description

The generator underwent product analysis and internal investigation showed that the generator battery prematurely depleted and the premature battery life indicators were predominately caused by conductive debris from the laser-routing process resulting in leakage paths.This is captured in mfr report # 1644487-2018-00755.The device history record of the generator was reviewed, and the device passed all functional specifications prior to release, it was also confirmed that the device was laser-routed during the manufacturing process.During analysis, interrogation and system diagnostic tests were performed, and resulted in ok communication, lead impedance, and current delivered for the generator.The pulse generator performed according to functional specifications with the exception of the expected low battery voltage.No other relevant information has been received to date.

• 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: 7230546
• MDR Text Key: 98747088
• Report Number: 1644487-2018-00125
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2011
• Device Model Number: 302-20
• Device Lot Number: 2143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/10/2018
• Initial Date FDA Received: 01/31/2018
• Supplement Dates Manufacturer Received: 03/06/2018; 04/05/2018; 04/30/2018
• Supplement Dates FDA Received: 03/28/2018; 04/30/2018; 05/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2008
• 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: 15 YR