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

Model Number 102

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

Patient Problem Pain (1994)

Event Date 11/09/2017

Event Type  Injury  

Event Description

It was reported that a patient wants to have her device removed.The patient reports that the device is now moving under her skin and is causing her pain and she wants it explanted.Additional relevant information has not been received to-date.No known surgery has occurred to-date.

Event Description

Follow-up from the treating provider indicated she was not sure of the cause of the migration, and that the device has been in place many years after it stopped working.

• Brand Name: PULSE GEN MODEL 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: 7081853
• MDR Text Key: 93680560
• Report Number: 1644487-2017-04929
• Device Sequence Number: 1
• Product Code: MUZ
• 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,consum
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2018

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: 05/31/2007
• Device Model Number: 102
• Device Lot Number: 013177
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/09/2017
• Initial Date FDA Received: 12/05/2017
• Supplement Dates Manufacturer Received: 01/09/2018
• Supplement Dates FDA Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2005
• 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: 55 YR