MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODL 102; GENERATOR

Model Number 102

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Pain (1994)

Event Date 10/29/2016

Event Type  Injury  

Event Description

It was reported that the patient was assaulted and fell off his bicycle.Immediately following the incident the patient began experiencing painful stimulation at the generator site.Over the next few days the patient experienced pain at the generator site, left arm, and the electrode site as well as pain with stimulation in his shoulder.The device was later disabled and a system diagnostics test found that the lead impedance was within acceptable limits.The patient was later referred for a vns replacement due to the pain.At the replacement surgery a new generator was connected to the existing lead and the impedance was found to be within acceptable limits.The surgeon evaluated the lead and noted that there was no obvious discontinuities or fluid in the lead.Therefore the surgeon decided to only replace the vns generator at that time.The explanted generator has not been received to date.No additional relevant information has been received to date.

Event Description

It was reported that the explanted generator was discarded and therefore product analysis cannot be completed on the generator.

Manufacturer Narrative

(b)(4).

Event Description

The explanted generator was received and underwent product analysis where it was confirmed that the generator was at neos = no.The generator was placed in a simulated body temperature environment and the output current was monitored for a 24 hour period.During this testing period no variations in the output of the generator were observed.Analysis found that the generator performed to functional specification.

• Brand Name: PULSE GEN MODL 102
• 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: 6158581
• MDR Text Key: 61906001
• Report Number: 1644487-2016-02822
• 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: Medical Assistant
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2017

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: 04/30/2007
• Device Model Number: 102
• Device Lot Number: 012991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/15/2016
• Initial Date FDA Received: 12/09/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/23/2017; 02/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2005
• 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: 53 YR