FDA Adverse Event Injury Summary report: N

PULSE GEN MODEL 102

MDR report key: 2103698 · Received May 23, 2011

Report

Report Number
1644487-2011-01132
Event Type
Injury
Date Received
May 23, 2011
Date of Event
May 2, 2011
Report Date
May 2, 2011
Manufacturer
CYBERONICS, INC.
Product Code
LYJ
PMA / PMN Number
P970003
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
TN, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

ON (B)(6) 2011 A VNS IMPLANTING SURGEON REPORTED THAT THE VNS PT WANTS TO HAVE HER DEVICE EXPLANTED BECAUSE SHE IS EXPERIENCING A "VOICE TICK", HEART FLUTTERING, COUGHING, AND NUMBNESS ON ONE SIDE OF CHEEK AND THROAT. THE PT HAD BEEN IMPLANTED (B)(6) 2011. SHE WAS SCHEDULED TO SEE HER NURSE PRACTITIONER ON (B)(6) 2011. ON (B)(6) 2011 CLINIC NOTES DATED (B)(6) 2011 FROM THE VNS TREATING NURSE PRACTITIONER WERE RECEIVED. THE CLINIC NOTES REPORT THAT THE PT IS EXPERIENCING AN UNCONTROLLED COUGH AND CLEARING OF THE THROAT (WORSE WITH STRESS), PAIN AT THE VNS GENERATOR SITE, NUMBNESS AND TINGLING TO CHIN THROUGH HER LEFT EAR/FACIAL, AND WAS VERY NERVOUS DESCRIBING THE INCREASING DISCOMFORT THE VNS HAS CAUSED. THE PT WENT FOR F/U WITH THE SURGEON AND AFTER THE PT TOLD HIM ABOUT THE NUMBNESS AND TINGLING HE SUGGESTED IMMEDIATE REMOVAL OF THE VNS. THE PT'S MEDICAL HISTORY LISTS MIGRAINE HEADACHES, ESOPHAGEAL REFLUX, AND TIA; IT IS UNK THE RELATIONSHIP OF THE EVENTS TO VNS. THE PT'S NEUROLOGICAL EXAM SHOWED HEADACHES ASSOCIATED WITH DIZZINESS AND SEIZURES AND THE PT FEELS LIKE HER DEVICE MOVES AROUND FROM THE CHEST AREA TO UNDER HER ARMPIT AT TIMES. THE PHYSICIAN IS REFERRING THE PT FOR VNS REMOVAL AND EDUCATED THE PT ABOUT HOW SOME OF HER SYMPTOMS MAY BE RELATED TO STRESS AND NOT COMPLETELY DUE TO VNS IMPLANT, SINCE THEY WERE ONGOING AFTER THE DEVICE WAS DISABLED THAT DAY. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFO FROM THE PT'S NURSE PRACTITIONER HAVE BEEN TO NO AVAIL THUS FAR.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 2537

Patients

Seq Age Sex Outcome Treatment
1 47 YR Required Intervention