MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Headache (1880); Neck Pain (2433)

Event Date 01/01/2017

Event Type  malfunction  

Event Description

Patient reported on social media that she started to have problems described to be bee sting like feeling shocks all over the left side of the body and in the patient¿s stomach.Patient reported pain around the brain stem.The patient reported that the pain was getting worse in the neck wire and was unbearable.The patient noted that she was seen by a physician a month ago and it was found that the device was malfunctioning therefore it was disabled.It was noted that the pain stopped after device disablement.The patient noted that she was referred for device explant.No known surgical intervention has occurred to date.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• 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: 8807124
• MDR Text Key: 151583124
• Report Number: 1644487-2019-01404
• 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: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/16/2015
• Device Model Number: 103
• Device Lot Number: 3794
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 06/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2013
• 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): Required Intervention
• Patient Age: 54 YR