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

Model Number 102

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Seizures, Absence (2261); Therapeutic Response, Decreased (2271)

Event Date 01/01/2013

Event Type  Injury  

Event Description

Clinic notes were received for a vns epilepsy patient¿s follow up visit with her neurologist in (b)(6) 2014.The notes indicate that, since her last office visit, the patient had been diagnosed with breast cancer and had double mastectomies and chemotherapy.The notes state that the vns device did not pose a problem structurally.The patient¿s seizures have remained controlled during cancer treatment.The patient reported not experiencing any convulsive seizures but had sporadic absence episodes.The patient is happy with her treatment approach.

Event Description

The physician reported that the patient's breast cancer is not caused by vns.

Manufacturer Narrative

(b)(6).Since the cancer is not related to vns, this event should not have been reported on a mdr.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 3648335
• MDR Text Key: 4194805
• Report Number: 1644487-2014-00533
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2005
• Device Model Number: 102
• Device Lot Number: 009946
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2004
• 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: 45 YR