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

Model Number 302-20

Device Problems Moisture Damage (1405); Split (2537); Battery Problem: High Impedance (2947)

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

Event Date 09/22/2016

Event Type  malfunction  

Event Description

It was reported by a company representative who attended a battery replacement surgery, that high lead impedance was discovered while performing pre-operative diagnostics, with results of ok/limit/high/dcdc-7.When the surgeon removed the previous generator and inspected the lead he observed that there was a large section of old lead casing that was split open.The surgeon couldn't tell if it was just outer casing or inner casing also, however there looked to be fluid inside the lead casing.The lead was resected off of the nerve and a new lead was implanted with the new generator.Additional relevant information has not been received to-date.The explanted devices have not been received by the manufacturer to-date.

Event Description

The explanted device was received (b)(6) 2016.Analysis is underway, but has not been completed to-date.

Event Description

Analysis was completed for the returned generator.The report of end of service and low battery were confirmed and was the result of normal, expected battery depletion.The device performed according to functional specifications and no abnormal performance or any other type of adverse condition was found.Analysis was completed for the returned lead.The report of lead fracture was not verified within the returned lead portion.The report of fluid leaks and a breach in the outer and inner tubing wall was verified.Abraded openings were identified in the outer silicone tubing and on the inner silicone tubing of the negative coil.Since a portion of the lead including the electrode array was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Other than typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

• 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: 6033396
• MDR Text Key: 57808282
• Report Number: 1644487-2016-02380
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/22/2016

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: 01/31/2009
• Device Model Number: 302-20
• Device Lot Number: 1509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/22/2016
• Initial Date FDA Received: 10/17/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/04/2016; 12/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2006
• 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: 18 YR