MAUDE Adverse Event Report: CYBERONICS, INC. BIPOL LEAD MODEL 300

Model Number 302-20

Device Problem Mechanical Problem (1384)

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

Event Date 08/18/2017

Event Type  malfunction  

Event Description

A patient was scheduled for prophylactic generator replacement.Before surgery, the lead impedance was within normal limits.After the generator was replaced, the lead impedance value was high.The lead pin was removed and placed again with the same results.The company representative stated there was possible separation of silicone from connector tip and kink in lead about 6 centimeters from the lead tip.The old lead was removed and a new lead was placed, and was reported to be fine.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 devices were received by the manufacturer.Analysis is underway, but has not been completed to-date.

Event Description

Analysis was completed for the returned generator and lead portions.Measurement of the battery voltage confirmed that the battery was depleted.Based on the bench analysis and the electrical test results, the device exhibited current consumption rates that were within specification, demonstrating normal battery depletion to an end of service condition.The generator performed according to functional specifications, and no abnormal performance or any other type of adverse condition was found with the generator.A lead fracture was not identified, however a portion of the lead connector was partially torn, and a firmly compressed area in the outer tubing and kinks in the lead coils may confirm the report.Since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot 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.

• Brand Name: BIPOL LEAD MODEL 300
• 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: 6860203
• MDR Text Key: 85939043
• Report Number: 1644487-2017-04448
• 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: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2009
• Device Model Number: 302-20
• Device Lot Number: 200371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2006
• 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: 34 YR