MAUDE Adverse Event Report: CYBERONICS - HOUSTON BIPOL LEAD MODEL 300

Model Number 300-20

Device Problem Fracture (1260)

Patient Problems Seizures (2063); Numbness (2415); No Code Available (3191)

Event Date 04/14/2017

Event Type  malfunction  

Event Description

It was reported that during an office visit on high impedance was observed as a result of a diagnostic test.The settings were not changed at that time.The patient reported that for the past 1-2 weeks she had been experiencing an increase in seizures and left jaw discomfort.She also had been stuttering for the previous 2 days and the vns magnet was not working the same as before.The patient was referred for surgery to address the high impedance but no surgical interventions are known to have occurred to date.

Event Description

It was reported that the patient's high impedance was intermittent and positional dependent.

Event Description

It was reported several years after the initial report that the patient did not perceive stimulation, which is an expected event based on the high impedance.It was stated that the patient had not had a replacement yet due to fear of the vns lead needing to be replaced.

• Brand Name: BIPOL LEAD MODEL 300
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6584365
• MDR Text Key: 75778126
• Report Number: 1644487-2017-03858
• 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,Followup
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2001
• Device Model Number: 300-20
• Device Lot Number: 20644C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/28/2017
• Initial Date FDA Received: 05/23/2017
• Supplement Dates Manufacturer Received: 04/12/2018; 04/20/2018; 01/17/2020
• Supplement Dates FDA Received: 04/13/2018; 05/09/2018; 02/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/1999
• 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 Outcome(s): Required Intervention
• Patient Age: 63 YR