MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; LEAD

Model Number 303-20

Device Problem Mechanical Problem (1384)

Patient Problems Neck Pain (2433); No Code Available (3191)

Event Date 09/15/2017

Event Type  malfunction  

Event Description

It was reported that a vns patient has had a recent change in behavior, becoming very agitated and feels like she is being shocked.Follow-up from the company representative who spoke to the physician provided that he thought it was due to the last increase in dose.He also said that the patient is very thin and you can feel the lead which he then said it might have felt like it was twisted but not sure.He referred the patient to the surgeon for a check of the lead.All diagnostics checked out fine.Further follow-up from the provider indicated that they found a wire that appeared to be kinked.The device was functioning with no errors and impedance was within normal limits.Additional relevant information has not been received to-date.

• Brand Name: PULSE GEN MODEL 106
• 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: 7019422
• MDR Text Key: 92212700
• Report Number: 1644487-2017-04759
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750115
• UDI-Public: 05425025750115
• 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
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2019
• Device Model Number: 303-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2015
• 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): Other
• Patient Age: 15 YR