MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problems Unexpected Therapeutic Results (1631); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Seizures (2063); Therapeutic Effects, Unexpected (2099); Vomiting (2144); Therapeutic Response, Decreased (2271)

Event Date 04/13/2016

Event Type  Injury  

Manufacturer Narrative

Event Description

It was reported to a case manager (b)(6) 2016 by a patient's caregiver that the patient was having problems with tolerance of stimulation settings in excess of 0.75 ma.She describes increased patient agitation as well as marked increase in seizures with each attempt to advance stimulation strength to 1.25 ma.The caregiver also was concerned about a change in seizures with onset of approx.6 months prior.She reported onset of monthly seizures the first of every month, characterized by emesis after seizure activity.The increase in seizures were reported to be worse than the patient's pre-vns baseline.The device settings were adjusted.Additional relevant information has not been received to-date.

Event Description

Follow-up from the treating physician provided that although the caregiver believes the increase in seizures is due to vns, the physician does not.The increase in seizures at higher settings of 1.25ma was not worse than before the patient had vns.The increase in seizures at settings of 0.75ma was not worse than before the patient had vns.Device diagnostics were provided and were within normal limits on (b)(6) 2016.Notes from (b)(6) 2016 received provided that the caregiver says when she does use the magnet during the seizure it seems like it makes the seizure worse.The patient¿s vns was decreased to 0.75 on (b)(6) 2016 due to agitation, since then she remained seizure free for 12 days until having a seizure.It was reported that in april behavioral problems of rage, biting, yelling and fussy were present.Average seizures still remains once a week.It was reported the patient wants to be off on vns.The vns was reduced from 0.75ma to 0.5 ma, and then was planned to be reduced to 0.25 ma and then turn it off.

Manufacturer Narrative

Date of this report, corrected data: the date of the report submission for follow-up report #1 was inadvertently provided as 11/01/2016, and was intended to be 01/05/2017.Date received by manufacturer, corrected data: the date the information was received by the manufacturer for follow-up report #1 was inadvertently provided as 12/09/2016, and was intended to be 12/08/2017.

Event Description

Further follow-up from the physician provided that the magnet mode was not making the seizures worse.

Event Description

Follow-up from the physician provided that the patient¿s device had been turned off on (b)(6) 2016.The patient is reported to have psych issues and the device was turned off to appease her even though the physician doesn't feel that her recent problems are related to vns.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• 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: 6071002
• MDR Text Key: 58918578
• Report Number: 1644487-2016-02539
• 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,consum
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/28/2017

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2016
• Device Model Number: 103
• Device Lot Number: 3886
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/13/2016
• Initial Date FDA Received: 11/01/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/05/2017; 01/23/2017; 03/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2014
• 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: 30 YR