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

Model Number 106

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

Patient Problems Arrhythmia (1721); Dyspnea (1816); Pneumonia (2011)

Event Date 09/07/2017

Event Type  Injury  

Event Description

The patient contacted the manufacturer to ask questions about the tachycardia detection feature of the m106 generator.While asking for more information the patient reported that a little over a week post implant surgery, she had developed shortness of breath, pneumonia and an increased heart rate which caused her to go to the hospital.The patient was placed on two antibiotics and referred back to her primary care physician for the treatment of the pneumonia & shortness of breath.A review of manufacturing records showed that both the lead and generator were sterilized prior to distribution.No additional relevant information has been received to date.

Manufacturer Narrative

Corrected data: describe event or problem; this information was inadvertently left off on mfg.Report #0.

Event Description

During the communication with the patient there was no allegation that the elevated heart rate, shortness of breath or pneumonia were related to the vns implant procedure or the vns device.The patient reported these symptoms during the communication to provide context to her questions regarding the tachycardia detection feature the vns generator and not to make an allegation against vns.

Manufacturer Narrative

Corrected data: unique identifier (udi); this information was inadvertently reported incorrectly on mfg.Report #0.

• 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: 6934594
• MDR Text Key: 89079041
• Report Number: 1644487-2017-04575
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2017

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: 01/12/2019
• Device Model Number: 106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 09/12/2017
• Initial Date FDA Received: 10/10/2017
• Supplement Dates Manufacturer Received: 10/25/2017; 12/12/2017
• Supplement Dates FDA Received: 10/25/2017; 12/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2017
• 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: 30 YR