MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Fever (1858); Pneumonia (2011); Urinary Retention (2119); No Code Available (3191); Constipation (3274)

Event Date 10/04/2017

Event Type  Injury  

Event Description

It was reported that after a recent generator replacement surgery the patient now has a depressed cough reflex and an increased heart rate of about 30 bpm higher.The patient's device was checked according to the nurse and appears to be working properly.The patient's neurologist increased her settings in response to the issues.Also, after the replacement surgery the patient was hospitalized with pneumonia.No additional or relevant information has been received to date.

Manufacturer Narrative

(b)(4).

Event Description

The neurologist indicated the relationship of the depressed cough reflex to vns is unknown, and that she was unable to assess the patient's arrhythmia and pneumonia.It was noted that the patient's heart rate increased preoperatively and returned to a normal value postoperatively.Also, information was received from the patient's neurologist that the patient was hospitalized with fever, constipation, urinary retention, hypoxia, gastric paresis, and dyspnea.Follow up was performed with the neurologist regarding these events.The neurologist stated the cause of these events was unknown as the patient was hospitalized at a separate facility, and she was unable to assess the patient directly.The neurologist was informed the patient had recovered completely and was discharged from the hospital.No additional or relevant information has been received to date.

Manufacturer Narrative

Describe event; corrected data; supplemental mdr #1 inadvertently omitted information that was known prior to submission.

Event Description

The pneumonia reported on supplemental report #1 occurred before the replacement surgery and it was also noted in this report that the patient's heart rate increased pre-operatively.Since these events occurred before the replacement surgery, they will be reported on report number 1644487-2018-00290.

• Brand Name: PULSE GEN MODEL 105
• 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: 7171999
• MDR Text Key: 96627416
• Report Number: 1644487-2018-00016
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750054
• UDI-Public: 05425025750054
• 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,Followup,Followup
• Report Date: 02/28/2018

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: 01/05/2019
• Device Model Number: 105
• Device Lot Number: 204029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/14/2017
• Initial Date FDA Received: 01/08/2018
• Supplement Dates Manufacturer Received: 01/31/2018; 02/28/2018
• Supplement Dates FDA Received: 02/22/2018; 02/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2017
• 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): Hospitalization; Other
• Patient Age: 20 YR