MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 105; GENERATOR

Model Number 105

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

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994)

Event Date 01/01/2018

Event Type  Injury  

Event Description

It was reported via letter of medical necessity received by the manufacturer that the patient complained of abnormal sensations ("electrical shocks" lasting for several seconds) in her body since last year.It was stated that this was when the patient was operating a microwave oven, but more commonly when weather disturbances/storms occurred nearby.Per the physician's labeling, properly operating microwave ovens, electrical ignition systems, power transmission lines, theft-prevention devices, and metal detectors are not expected to affect the generator.It was reported as more common recently and that the vns was disabled due to the sensations of the vns " firing off suddenly" even with no seizures reported by the patient.The patient's vns model did not have sensing capabilities and, therefore, did not provide stimulation based on tachycardia detection related to seizures, but due to the programmed on and off times.The physician felt that the current vns should be removed and replaced with the latest model as soon as possible as the patient had a good response to vns therapy.

Event Description

It was later reported that the patient's vns had been programmed off.It was reported by the patient that she had lost weight, has had her medications increased, has been feeling horrible, and has been experiencing more and more seizures since the disablement of the device.

Event Description

The patient underwent prophylactic vns generator replacement surgery.During attempts for product return, it was revealed that the explanted product was discarded.

Manufacturer Narrative

Describe event or problem, corrected data: initial report inadvertently listed "per the physician's labeling, properly operating microwave ovens, electrical ignition systems, power transmission lines, theft-prevention devices, and metal detectors are not expected to affect the generator." instead of "per the manufacturer's labeling, properly operating microwave ovens, electrical ignition systems, power transmission lines, theft-prevention devices, and metal detectors are not expected to affect the generator" and left out follow up information from physician.Relevant tests/laboratory data, corrected data: initial report inadvertently left out settings and diagnostics obtained during follow up with the physician.(b)(4).

Event Description

Per the manufacturer's labeling, properly operating microwave ovens, electrical ignition systems, power transmission lines, theft-prevention devices, and metal detectors are not expected to affect the generator.Follow up with the physician's office revealed that the patient reported not swiping the magnet and feeling continuous or sudden stimulation.No relevant surgery is known to have occurred to date.

• Brand Name: PULSE GEN MODEL 105
• 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: 8809058
• MDR Text Key: 151642785
• Report Number: 1644487-2019-01416
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750054
• UDI-Public: 05425025750054
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/17/2020

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/12/2019
• Device Model Number: 105
• Device Lot Number: 204195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2017
• 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): Required Intervention
• Patient Age: 44 YR