MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Programming Issue (3014)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)

Event Date 10/05/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported on (b)(6) 2016 from the physician that the patient was experiencing bradycardia and the physician wanted to check the patient's device to see if vns was the cause.The patient has reported developed prolonged (hours) of hypotension and bradycardia with decreased responsiveness.The device was then programmed off.Diagnostics from (b)(6) 2016 were within normal limits.Since turning off the device the patient was sent home on halter monitor for further event monitoring as the events did not happen while in hospital.It was stated that his bradycardic events are sporadic and not daily and not stimulation dependent.It was also stated neurology wasn't comfortable leaving vns on at discharge until further work up and diagnosis was determined.But it seems no conclusion on the cause of the bradycardia and hypotension was determined.

Manufacturer Narrative

Initial mdr inadvertently omitted the type of intervention taken for the adverse events.

Event Description

The patient was in the hospital due to bradycardia.

• Brand Name: PULSE GEN MODEL 106
• 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: 6064287
• MDR Text Key: 58663182
• Report Number: 1644487-2016-02512
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/05/2016

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: 03/03/2018
• Device Model Number: 106
• Device Lot Number: 4792
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/05/2016
• Initial Date FDA Received: 10/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2016
• 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: 37 YR