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

Model Number 106

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

Patient Problems Diarrhea (1811); No Code Available (3191)

Event Date 02/26/2019

Event Type  Injury  

Event Description

It was reported that the patient had abdominal pain and nausea and the physician questioned if the patient¿s electrodes had been placed correctly.The patient was at 0.75ma output current, and was asked to practice with the vns magnet providing 1ma stimulation once or twice a week.When the patient practiced with the magnet she experienced massive abdominal pain.The patient was ramped up to normal output current 1ma.Two weeks later, the patient had reduced continuous abdominal pain.The duty cycle was changed.Two weeks after that, the patient stated that the pain was reduced further but still not gone.The frequency was lowered from 30 hz to 20 hz.After a month, the patient still had pain and developed symptoms of diarrhea and no appetite.The patient¿s general practitioner had no assessment of the symptoms.The patient¿s device was disabled at the request of the patient and the pain resolved.X-rays were received and reviewed for the patient.Per the x-rays, the generator placement appeared to be normal in the left axillary chest area.Complete pin insertion was confirmed as the pin can be seen coming through the second connector block.The feed through wires, and the lead wire continuity appeared normal.The lead was observed in the neck and chest.Part of the lead appears to be behind the generator and could not be assessed.In the portions of the lead visible, no gross lead fractures or other anomalies were observed.The electrodes are placed correctly, as there is a single wire present on the top electrode, and double wires present after the second electrode, indicating proper orientation.Note that the presence of a micro fracture and/or a lead discontinuity cannot be ruled out in the portion of the lead that is not visible in the provided images.No additional or relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8445038
• MDR Text Key: 139597982
• Report Number: 1644487-2019-00577
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/22/2019

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: 02/06/2020
• Device Model Number: 106
• Device Lot Number: 204383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/26/2019
• Initial Date FDA Received: 03/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2018
• 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: 39 YR