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

Model Number 300-20

Device Problems High impedance (1291); Battery Problem (2885)

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

Event Date 08/19/2016

Event Type  malfunction  

Event Description

It was reported that a vns patient who was scheduled for a battery replacement due to eos was found to have high lead impedance at pre-operative diagnostics check.The battery replacement surgery was cancelled to be rescheduled at a later date for lead revision as well.Additional relevant information has not been received to-date.No known surgery has occurred to-date.

Event Description

Follow-up from the provider's office indicated the lead was fractured.

Event Description

The patients full vns replacement surgery occurred on (b)(6) 2016.Lead impedance on the replacement system was within normal limits at the time of implant.The explanting facility will not return explanted products, so device return is not expected.No additional pertinent information has been received to date.

• 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: 5951772
• MDR Text Key: 55134512
• Report Number: 1644487-2016-02080
• 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: 08/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2001
• Device Model Number: 300-20
• Device Lot Number: 24060C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/1999
• 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: 60 YR