MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 104; GENERATOR

Model Number 104

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

Patient Problems Dysphagia/ Odynophagia (1815); Low Blood Pressure/ Hypotension (1914); Vomiting (2144)

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The patient's mother reported that the patient had been in the hospital due to vomiting, gagging, pain under each arm, hiccups and hypotension.The patient's vns was disabled for 24 hours in the hospital.When the device was off, there was no gagging and vomiting.When it was turned back on, the gagging and vomiting was less.The patient had reportedly lost 5 pounds since the vomiting started.After a full gi work-up, nothing but gastric irritation was found.The treating physicians in the hospital didn't think that the vns was the cause, but they wanted to further investigate and confirm this.The patient's mother reported that the treating physician said that her daughter was using the magnet too often.The patient was in the hospital for approximately 2 weeks.The patient's mother also reported that the patient was now experiencing pain at the generator site.When the patient saw another doctor for follow-up, he did believe that the patient's vomiting, nausea, pain at chest, under arms, hypotension and hiccups were related to the vns stimulation.He indicated that the patient's output current was too high at 2.75 ma, so he decreased it to 2.5 ma due to the vomiting and hiccups.No device error was noted by the physician.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 104
• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8036490
• MDR Text Key: 126062529
• Report Number: 1644487-2018-01980
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750047
• UDI-Public: 05425025750047
• 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: Other
• Type of Report: Initial
• Report Date: 11/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/15/2017
• Device Model Number: 104
• Device Lot Number: 203398
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 10/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2015
• 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
• Patient Age: 25 YR