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

Model Number 102R

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Seizures (2063); Therapeutic Response, Decreased (2271)

Event Date 09/02/2016

Event Type  Injury  

Event Description

Clinic notes were received for a patient's generator replacement surgery, and it was noted that the patient's seizures were not well controlled.The patient reported to the physician that she experienced an increase in seizures.However, the physician did not have any details regarding the increase in seizures.System diagnostic results were within normal limits, indicating proper device function.No further relevant information has been received to date.

Manufacturer Narrative

Udi of suspect device was inadvertently left off the initial report.(b)(4).

• Brand Name: PULSE GEN MODEL 102R
• 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: 6143420
• MDR Text Key: 61400126
• Report Number: 1644487-2016-02784
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 11/07/2016

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: 01/14/2017
• Device Model Number: 102R
• Device Lot Number: 4266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/07/2016
• Initial Date FDA Received: 12/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2015
• 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): Other
• Patient Age: 34 YR