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 Problem No Code Available (3191)

Event Date 11/21/2017

Event Type  malfunction  

Event Description

Clinic notes from a visit on (b)(6) 2017 were received indicating that a vns patient¿s device is skipping.The patient reports that he does not feel good, and the vns is giving him erratic stimulation.He reports pain with stimulation, and reports the vns is making him sick.The device was turned down which helped, but did not stop it.It was reported the device was malfunctioning and referral was made for replacement.On a visit dated (b)(6) 2017 it was reported the vns was giving him abnormal impulses.He reported the vns was checked with the wrong device and since it has been giving him abnormal shocks.The diagnostics were reported to be okay.Additional relevant information has not been received to-date.

Event Description

Generator revision surgery occurred (b)(6) 2018.The explant facility does not return products to the manufacturer.

• 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: 7159246
• MDR Text Key: 96205344
• Report Number: 1644487-2018-00008
• 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: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/22/2011
• Device Model Number: 103
• Device Lot Number: 2419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2009
• 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: 55 YR