MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

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

Patient Problems Pain (1994); Neck Pain (2433)

Event Date 06/22/2017

Event Type  Injury  

Event Description

It was reported to a company representative that a patient has requested to have her device removed due to pain at the generator site.She is diagnosed with mental health problems and the patient¿s physician believes the pain is mostly psychological.Additional relevant information has not been received to-date.No known surgery has occurred to-date.

Event Description

Follow-up from the company representative who spoke to the provider indicated that the patient also had pain in the neck from when her grandson had slapped her on the neck.The device was turned off for a couple of weeks and was turned back on with no discomfort and the problem was considered resolved.

Event Description

Follow-up from the provider indicated that the neck pain had resolved and the most recent diagnostics were okay.

Event Description

Further follow-up from the provider indicated that trauma to the neck has partially dislodged, damaged the electrode and was causing pain.Lead revision surgery occurred, and the explanted device has not been received by the manufacturer to-date.

Manufacturer Narrative

Event description, corrected data: it was inadvertently not provided on follow-up report #3 that the device had been received by the manufacturer.

Event Description

The explanted device was received by the manufacturer.Documentation received indicated that the patient felt a lead pulling sensation and then painful stimulation.Analysis is underway, but has not been completed to-date.

Manufacturer Narrative

Event description, corrected data: the results of product analysis for the returned generator were inadvertently not provided in follow-up report #4.

Event Description

Analysis was completed for the returned lead.The electrode array portion was not returned for analysis, and evaluation could not be made on that portion of the lead.Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.

• Brand Name: PULSE GEN MODEL 103
• 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: 6727567
• MDR Text Key: 80512224
• Report Number: 1644487-2017-04170
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2016
• Device Model Number: 103
• Device Lot Number: 3991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2014
• 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