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

Model Number 300-20

Device Problems High impedance (1291); Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 10/20/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014 it was reported that the patient had high impedance during a system and normal mode diagnostics test.It was also noted that the patient¿s battery is near end of service.The patient was referred for a full revision surgery.Although surgery is likely, it has not occurred to date.

Event Description

On (b)(6) 2015 it was reported that the patient underwent a full revision surgery due to high impedance and end of service.It was reported that the generator was unable to be interrogated due to end of service.The generator and lead were received for product analysis on 02/10/2015.Product analysis is underway and has not yet been completed.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

On 02/25/2015 product analysis was competed on the generator.The generator was found to be at end of service and was determined to be the result of normal battery depletion.Based on the electrical test results, the device exhibited current consumption rates that are within specification, thereby demonstrating normal battery depletion to an end-of-service condition.A battery life estimation resulted in 3.00 years remaining before the eri flag would be set.However, an incomplete programming history (8.5-year gap) indicates the estimation does not use all the data required to make an accurate estimation.Therefore, the electrical performance of the generator, as measured in the product analysis lab, will be used to conclude that no anomalies exist and the eos condition is an expected event.The pulse generator module performed according to functional specifications; there was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.Product analysis on the lead was completed on 03/04/2015.Which confirmed discontinuity of the positive quadfilar coil in the body region of the returned lead portions; also observed abraded openings of the inner tubing near the break location.A break was identified in the positive coil at two locations.Scanning electron microscopy images of the positive coil end, positive coil segment, and strands segments show that pitting or electro-etching conditions have occurred at the break locations.However, due to metal dissolution and/or surface contamination the fracture mechanism cannot be ascertained.The inner silicone tubing of the lead coils has abraded openings at the ends.The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing.No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion.Since a portion of the lead (including the unmarked connector and the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

• Brand Name: BIPOL LEAD MODEL 300
• 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: 4242379
• MDR Text Key: 4989103
• Report Number: 1644487-2014-02983
• Device Sequence Number: 1
• Product Code: MUZ
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2002
• Device Model Number: 300-20
• Device Lot Number: 739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2000
• 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: 56 YR