FDA Adverse Event Injury Summary report: N

PULSE GEN MODEL 105

MDR report key: 3963844 · Received July 29, 2014

Report

Report Number
1644487-2014-01879
Event Type
Injury
Date Received
July 29, 2014
Date of Event
March 15, 2013
Report Date
July 1, 2014
Manufacturer
CYBERONICS INC
Product Code
LYJ
PMA / PMN Number
P970003
Removal / Correction Number
NA
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
TX, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

CLINIC NOTES DATED (B)(6) 2014 NOTE THAT SINCE THE PATIENT'S LAST VISIT ON (B)(6) 2013, THE PATIENT HAS EXPERIENCED AN INCREASE IN SEIZURES. IT WAS NOTED THAT THE PATIENT'S LAMICTAL WAS INCREASED AND THE PATIENT'S SEIZURES IMPROVED. IT WAS NOTED THAT THE PATIENT SUFFERED A SECOND INCREASE IN SEIZURES IN SEPTEMBER 2013. IT WAS NOTED THAT THE LAMICTAL WAS INCREASED A SECOND TIME; HOWEVER, LITTLE IMPROVEMENT WAS SEEN. IT WAS NOTED THAT THE PATIENT'S SEIZURES WENT FROM ONE SEIZURE A MONTH TO 4-5 SEIZURES A MONTH. IT WAS NOTED THAT THE SEIZURES TEND TO OCCUR TWO WEEKS PRIOR TO HER MENSES AND EITHER THE WEEK OF OR THE WEEK AFTER HER MENSES. THE SEIZURES OFTEN OCCUR IN PAIRS; SHE HAS A SEIZURE IN THE EVENING AROUND DINNER TIME AND ONE THE FOLLOWING MORNING SEVERAL HOURS AFTER AWAKENING. THE NOTES INDICATE THAT THE PATIENT'S SEIZURES HAVE CHANGED IN CHARACTER SINCE (B)(6) 2013. IT WAS NOTED THAT THE PATIENT NOW BECOMES STILL AND "FALLS LIKE A TREE, OFTEN ON HER FACE". IT WAS NOTED THAT IN THE PAST HER HABITUAL SEIZURES WERE DESCRIBED AS STARING AND LIP SMACKING. INITIALLY, THE INCREASE AND CHANGE IN SEIZURES WAS REPORTED ON MFR. REPORT # 1644487-2014-01499 AS THE INCREASE AND CHANGE IN SEIZURES WERE THOUGHT TO BE RELATED TO THE HIGH IMPEDANCE EVENT IN THIS REPORT. INFORMATION RECEIVED ON (B)(6) 2014 INDICATES THAT THE INCREASE AND CHANGE IN SEIZURES OCCURRED PRIOR TO THE HIGH IMPEDANCE EVENT. IT IS UNKNOWN IF THE INCREASE IN SEIZURES IS ABOVE THE PATIENT'S PRE-VNS BASELINE FREQUENCY. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
440805 PULSE GEN MODEL 105 GENERATOR LYJ CYBERONICS INC 105 202091

Patients

Seq Age Sex Outcome Treatment
1 15 YR Required Intervention