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); No Code Available (3191)

Event Date 03/29/2017

Event Type  Injury  

Event Description

It was reported that the patient's generator had migrated, and the patient was referred for surgery.It was unknown if trauma or manipulation had occurred that could have caused or contributed to the migration.The patient later reported that the patient was experiencing pain with the migration and was going to have surgery.No surgical intervention has occurred to date.

Event Description

Clarification was received that the pain and migration was not related to the previous trauma.The physician believed the cause of the pain and migration was musculoskeletal.The surgery was planned for patient comfort only.No surgical intervention has occurred to date.

Manufacturer Narrative

Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.

Event Description

The patient had generator replacement surgery.No analysis is necessary as the functionality of the device was not related to the reported events.

Event Description

As supplemental/adjunctive information, analysis was completed on the generator, and there were no performance or any other type of adverse conditions found with the pulse generator.

• 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: 6515064
• MDR Text Key: 73448707
• Report Number: 1644487-2017-03662
• 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: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2015
• Device Model Number: 103
• Device Lot Number: 202518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/02/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/04/2013
• 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: 30 YR