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

Model Number 300-20

Device Problems Degraded (1153); High impedance (1291)

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

Event Date 07/28/2015

Event Type  malfunction  

Event Description

It was reported that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015 due to high impedance.The explanted devices have not been returned to date.Attempts for additional relevant information will be made.

Event Description

A physician assistant provided information that the high impedance was identified on (b)(6) 2015 during a routine follow-up.It was identified from a system diagnostic test with dcdc 7.She also indicated that the lead was fractured.The explanting facility discarded the explanted devices; therefore, no analysis can be performed.

• 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: 5050379
• MDR Text Key: 25432368
• Report Number: 1644487-2015-05684
• 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 Assistant
• Report Date: 08/06/2015

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: 02/29/2004
• Device Model Number: 300-20
• Device Lot Number: 5213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2002
• 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: 52 YR