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

Model Number 302-20

Device Problem Disconnection (1171)

Patient Problem No Code Available (3191)

Event Date 02/24/2015

Event Type  malfunction  

Event Description

Analysis of the generator was completed.The pulse generator performed according to functional specifications.The battery showed an ifi=no condition.The data in the diagaccumconsumed memory locations revealed that 43.645% of the battery had been consumed.No performance or any other type of adverse conditions was found with the pulse generator.

Event Description

The explanted devices were received by the manufacturer on 04/20/2015.Analysis is underway, but it has not been completed to date.Analysis of the lead was completed.Scanning electron microscopy images of the connector pin show that the pitting or electro-etching conditions have occurred on the pin surface at the setscrew marks¿ location.No obvious adverse effect was identified on the device performance as a result of this condition.A portion of the lead including the electrode array was not returned for analysis, rendering an evaluation and resulting commentary on that portion of the lead impossible.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

Manufacturer Narrative

Only a portion of the lead was returned for analysis which did not reveal any anomalies.Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

Event Description

An implant card was received indicating that the patient underwent generator and lead replacement due to lead discontinuity.The lead impedance with the new system was within normal limits (1793 ohms).The explanted devices are expected to be returned for analysis, but have not been received to date.No additional relevant information has been received to date.

Manufacturer Narrative

Device failure occurred, 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: 4641405
• MDR Text Key: 5833658
• Report Number: 1644487-2015-04291
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2015

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: 06/30/2006
• Device Model Number: 302-20
• Device Lot Number: 10789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/18/2015
• Initial Date FDA Received: 03/30/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/15/2015; 05/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2004
• 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: 59 YR