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

Model Number 102

Device Problem Insufficient Information (3190)

Patient Problem Swelling (2091)

Event Date 01/28/2016

Event Type  Injury  

Manufacturer Narrative

Event Description

It was reported that the patient is scheduled for a prophylactic generator change and lead reposition.She has a left breast tumor that is also being removed at the same time.Good faith attempts to the physician for additional information regarding the tumor have been unsuccessful.Although surgery is likely, it has not occurred to date.

Event Description

On (b)(6) 2016 the patient had a prophylactic generator replacement.The surgery was done in conjunction with a left breast biopsy.The lead was tunneled and relocated to the right breast.

Manufacturer Narrative

Follow-up #, corrected data: supplemental #1 inadvertently had the follow-up # as blank and not selected.

Event Description

The patient was being referred for possible revision because she is getting ready to do radiation for breast cancer.She had previously had a tumor removed on her left breast.No additional relevant information has been received to date.

• 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: 5450833
• MDR Text Key: 38662891
• Report Number: 1644487-2016-00377
• 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
• Report Date: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/30/2010
• Device Model Number: 102
• Device Lot Number: 200880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2008
• 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: 50 YR