MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Energy Output Problem (1431)

Patient Problems Dyspnea (1816); Pain (1994); Chest Tightness/Pressure (2463)

Event Date 05/02/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a vns patient was complaining of sporadic painful stimulation at the generator site and radiating down through his left arm starting.Clinic notes received indicate the symptoms started on (b)(6) 2016 and were more intense with magnet activation.The condition progressed to constant sensation of tightness in chest and shortness of breath of approx.1 hour duration until he taped the magnet over the device.The symptoms were alleviated for around 24 hours following pulse width adjustment from 500usec to 250usec and frequency adjustment from 30hz to 20hz on (b)(6) 2016 but then recurred.Full diagnostics were performed on (b)(6) 2016 and lead impedance on (b)(6) 2016 was normal 3,093 ohms.It was stated that the lead impedance was checked in varying neck positions.The physician elected to disable the device on (b)(6) 2016 and the patient was referred to a surgeon for anticipated exploratory surgery to explant and replace generator due to presumed malfunction/bleeding of current of vns system.X-rays were taken but nothing conclusive could be diagnosed by the providers.The x-rays were not provided to the manufacturer for review.The generator was successfully explanted and replaced on (b)(6) 2016 with no complications noted.The explanted generator was discarded by the explanting facility.

Event Description

An implant card was subsequently received for the procedure on (b)(6) 2016 indicating that a normal lead impedance of 3,373 ohms was observed with the newly implanted generator in place.

• Brand Name: PULSE GEN MODEL 106
• 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: 5685905
• MDR Text Key: 46165141
• Report Number: 1644487-2016-01156
• 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
• Report Date: 05/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/29/2017
• Device Model Number: 106
• Device Lot Number: 4553
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2015
• 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): Required Intervention
• Patient Age: 27 YR