FDA Adverse Event Injury Summary report: N

LEAD MODEL 304

MDR report key: 1851110 · Received September 30, 2010

Report

Report Number
1644487-2010-02209
Event Type
Injury
Date Received
September 30, 2010
Date of Event
June 1, 2010
Report Date
August 31, 2010
Manufacturer
CYBERONICS, INC.
Product Code
LYJ
PMA / PMN Number
P970003
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
PR, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

IT WAS REPORTED THAT A VNS PATIENT EXPERIENCED A LOSS IN APPETITE AND VOMITING AFTER EATING. THE EVENT BEGAN AFTER RECENT FULL REVISION SURGERY THAT OCCURRED ON (B)(6)2010, BUT NOT UNTIL THE DEVICE WAS PROGRAMMED ON. THE EVENT HAS BEEN OCCURRING SINCE THE DEVICE WAS PROGRAMMED ON BY THE MD. THERE HAS BEEN A MEDICATION CHANGE, WHICH WAS A DECREASE IN KEPPRA AS IT WAS NO LONGER NEEDED AFTER THE VNS DEVICE WAS PROGRAMMED BACK ON. THE PATIENT'S DEVICE WAS PROGRAMMED OFF BY THE TREATING NEUROLOGIST FOR ABOUT A WEEK AND PROGRAMMED BACK ON. THE EVENTS OF VOMITING AND WEIGHT LOSS DID NOT RESOLVE WHEN THE DEVICE WAS OFF. MOREOVER, AN EXAMINATION WAS MADE BY AN ENT AND FOUND THE PATIENT'S ESOPHAGUS TO BE INFLAMED DUE TO UNKNOWN REASON. ADDITIONAL INFORMATION WAS RECEIVED FROM THE ENT PHYSICIAN INDICATING THE PATIENT WAS SCHEDULED TO UNDERGO AN ENDOSCOPY. FURTHERMORE, FOLLOW-UP WAS MADE WITH THE ENT WHICH REVEALED THERE WAS NO PROBLEM OR ISSUES VISUALIZED WITH THE ENDOSCOPY. BIOPSY SAMPLES WERE TAKEN AND RESULTS WERE NORMAL. HOWEVER, THE ENT DID FIND A LOT OF SECRETION IN THE STOMACH. NO STOMACH BLEEDING WAS OBSERVED OTHER THAN THE BIOPSY SAMPLES WHICH IS NORMAL SINCE THE SKIN IS BEING PIERCED. AT THIS TIME, THE ENT COULD NOT ASSESS THE EVENT OF RELATIONSHIP TO VNS AS HE WAS WAITING ON A GASTRIC EMPTYING TEST. GOOD FAITH ATTEMPTS TO THE TREATING NEUROLOGIST AT THIS TIME HAVE BEEN UNSUCCESSFUL TO DATE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 LEAD MODEL 304 LYJ CYBERONICS, INC. 304-20

Patients

Seq Age Sex Outcome Treatment
1 15 YR Required Intervention